\
S. Hrg. 98-1055
THE POTENTIAL ENVIRONMENTAL CONSEQUENCES
OF GENETIC ENGINEERING
HEARINGS
BEFORE THE
SUBCOMMITTEE ON TOXIC SUBSTANCES
AND ENVIEONMENTAL OVERSIGHT
OF THE
COMMITTEE ON
ENVIRONMENT AND PUBLIC WOEKS
UNITED STATES SENATE
NINETY-EIGHTH CONGRESS
SECOND SESSION
SEPTEMBER 25 AND 27, 1984
Printed for the use of the Committee on Environment and Public Works
39-383 O
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1984
S. Hrg. 98-1055
THE POTENTIAL ENVIRONMENTAL CONSEQUENCES
OF GENETIC ENGINEERING
HEARINGS
BEFORE THE
SUBCOMMITTEE ON TOXIC SUBSTANCES
AND ENVIRONMENTAL OVEBSIGHT
OF THE
COMMITTEE ON
ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
NINETY-EIGHTH CONGRESS
SECOND SESSION
SEPTEMBER 25 AND 27, 1984
Printed for the use of the Committee on Environment and Public Works
39-383 O
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1984
COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
ROBERT T. STAFFORD, Vermont, Chairman
HOWARD H. BAKER, Jr., Tennessee JENNINGS RANDOLPH, West Virginia
JOHN H. CHAFEE, Rhode Island LLOYD BENTSEN, Texas
ALAN K. SIMPSON, Wyoming QUENTIN N BURDICK, North Dakota
JAMES ABDNOR, South Dakota GARY HART, Colorado
STEVE SYMMS, Idaho DANIEL PATRICK MOYNIHAN, New York
PETE V. DOMENICI, New Mexico GEORGE J MITCHELL, Maine
DAVE DURENBERGER, Minnesota MAX BAUCUS, Montana
GORDON J. HUMPHREY, New Hampshire FRANK R. LAUTENBERG, New Jersey
DANIEL J. EVANS, Washington
Bailey Guard, Staff Director
John W. Yago, Jr., Minority Staff Director
Subcommittee on Toxic Substances and Environmental Oversight
DAVE DURENBERGER, Minnesota, Chairman
ALAN K. SIMPSON, Wyoming MAX BAUCUS, Montana
JAMES ABDNOR, South Dakota QUENTIN N BURDICK, North Dakota
GORDON J. HUMPHREY, New Hampshire GARY HART, Colorado
(ID
CONTENTS
September 25, 1984
Page
Durenberger, Hon. Dave, U.S. Senator from the State of Minnesota, opening
statement of 1
WITNESSES
Alexander, Dr. Martin, professor, Department of Agronomy, Cornell Universi-
ty 20
Written statement 64
Brill, Dr. Winston, vice president, research and development, Agracetus Corp . 23
Written statement 75
Kendrick, Dr. Edgar L., Administrator, Office of Grants and Program Sys-
tems, Department of Agriculture 6
Written statement 49
MacLachlan, Dr. Alexander, director. Central Research and Development
Department, E.I. du Pont de Nemours 18
Written statement 55
Moore, Dr. John A., Assistant Administrator, Pesticides and Toxic Sub-
stances, Environmental Protection Agency 4
Written statement 42
Talbot, Dr. Bernard, Acting Director, National Institute of Allergy and Infec-
tious Diseases, National Institutes of Health 2
Written statement 33
September 27, 1983 (p. 81)
Durenberger, Hon. Dave, U.S. Senator from the State of Minnesota, opening
statement of 81
WITNESSES
Doyle, Jack, Director, Agricultural Resources Project, Environmental Policy
Institute 91
Written statement 148
Jackson, David A., senior vice president and chief scientific officer, Genex
Corp 82
Written statement 131
Rifkin, Jeremy, president, the Foundation on Economic Trends 96
Written statement 200
Simberloff, Dr. Daniel S., Department of Biological Science, Florida State
University 87
Written statement 139
ADDITIONAL MATERIAL
McGarity, Thomas O., professor of law. University of Texas, statement of 114
(III)
THE POTENTIAL ENVIRONMENTAL
CONSEQUENCES OF GENETIC ENGINEERING
TUESDAY, SEPTEMBER 25, 1984
U.S. Senate,
Committee on Environment and Public Works,
Subcommittee on Toxic Substances
AND Environmental Oversight,
Washington, DC.
The subcommittee met, at 10:08 a.m., in room SD-406, Dirksen
Senate Office Building, Hon. Dave Durenberger (chairman of the
subcommittee) presiding.
Present: Senator Durenberger.
OPENING STATEMENT OF HON. DAVE DURENBERGER, U.S.
SENATOR FROM THE STATE OF MINNESOTA
Senator Durenberger. The hearing will come to order.
Good morning everyone. Today and again on Thursday morning
we will consider a subject that not very long ago fell into the realm
of science fiction: the subject of genetic engineering and its poten-
tial consequences on our environment.
Genetic engineering is one aspect of the burgeoning biotechnol-
ogy industry, an industry that uses and alters living organisms to
create products. By manipulating genetic material, scientists can
now deliberately redraw the fundamental blueprints of living
things.
That is an awesome prospect. A chance to improve the quality of
life worldwide. New bacteria that will clean up oil spills, produce
rare drugs, and create super crops that resist disease and make
their own fertilizer. What better use of science than to protect our
environment, cure the sick, and feed the hungry?
We are enthusiastic and optimistic about this new technology,
and we should be. But we are also a little wary and a little fright-
ened. And I suppose we should be.
Do we really understand the consequences of these powerful new
tools? In our haste to gain the obvious benefits, might we cause un-
intended harm?
Let me mention one example I have come across in my reading.
Apparently scientists are working to create a bacterium that di-
gests lignin, a component of plant cells that resists decomposition.
If an organism can be engineered to break down lignin, then plant
material will yield more energy in a biomass conversion system.
We would be one step closer to an alternative energy supply.
(1)
But plants contain lignin for a very good reason. It helps them
resist disease. And because it is so resistant to decay, lignin helps '?
maintain the fertility in soil.
Shouldn't we think very carefully about creating a microorga-
nism that could destroy the productivity of our agricultural soils?
I do not claim to be an expert on this particular case, and there
may be good scientific reasons that make it perfectly safe. The
point is this: A situation is developing in which our ability to main-
pulate nature — to rearrange the building blocks of life — outstrips
our ability to predict the consequences.
But that is always the way of science. The breakthrough comes,
and we do our best to deal with the implications. That is why we
have called these hearings: to begin asking the questions about the
benefits and risks of this new industry to our environment.
I think you will find these hearings unusual. First of all, because
the subject is an exotic technology that very few people — especially
Senators — know very much about; and second, because our inquiry
is prospective.(All too often Congress acts in a sort of damage-con-
"tr^ capacity, trying to solve or minimize an environmental prob-
lem that has already become major. This time we have a^chance to
prevent harm before it occurs. —— . .. .
I hope we can address soiTre basic questions during these 2 days
of hearings. First, does genetic engineering present the possibility
of significant harm to the environment? And second, is the existing
patchwork of statutes, regulations and guidelines adequate to pre-
vent any potential problems? I understand the EPA will be issuing
regulations before long to regulate the products of biotechnology
under two existing toxic substance laws, and I will be interested to
hear more on that subject.
In dealing with these questions, I would urge our witnesses to re-
member they are addressing a lay audience, so please try to keep
the technical jargon to a minimum, if possible, and also please try
to observe the 10-minute limit so that everyone has a chance to be
heard this morning.
I appreciate the attendance today of all of our witnesses, and I
will indicate in advance that their prepared testimony will be
made a part of the hearing record if they choose to summarize.
I will call now our first panel: Dr. Bernard Talbot, Acting Direc-
tor, National Institute of Allergy and Infectious Diseases, National
Institutes of Health; Dr. John A. Moore, Assistant Administrator,
Pesticides and Toxic Substances, Environmental Protection
Agency; and Dr. Edgar L. Kendrick, Administrator, Office of
Grants and Program Systems, Department of Agriculture.
We will proceed with Dr. Talbot.
STATEMENT OF DR. BERNARD TALBOT, ACTING DIRECTOR, NA-
TIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES,
NATIONAL INSTITUTES OF HEALTH
Dr. Talbot. Thank you.
I have been associated since 1975 with the original preparation
and with all subsequent revisions of the NIH Guidelines for Re-
search Involving Recombinant DNA Molecules. These safety stand-
//^ 6 ^//
/. y
tJ J J^/'-y^^'-y-^ /^i/^*-^^^
ards were developed in response to a request by scientists that the
NIH devise such guidelines.
Overseeing the NIH guidelines is the Recombinant DNA Adviso-
ry Committee, called RAC for short. The RAC consists of 25 voting
members plus nonvoting representatives of many Federal agencies.
The voting members include eminent scientists of many different
disciplines, a lawyer who is the current chairman, a former State
legislator, an occupational safety expert, a housewife, practicing
physicians, and a bioethicist. Federal agencies with representatives
on the RAC include the Department of Agriculture and the Envi-
ronmental Protection Agency.
Since December 1978, the Guidelines have required that deliber-
ate release into the environment of any organism containing re-
combinant DNA must have prior approval by the NIH, following
review by the RAC, with opportunity for public comment and ap-
proval by the local institutional biosafety committee.
To date, three such cases of deliberate release have been ap-
proved by NIH. In each of these cases:
First, notice was placed in the Federal Register at least 30 days
prior to the RAC meeting at which the proposal was discussed,
giving notice and inviting public comment on the proposal.
Then the proposal was discussed at an open session of a RAC
meeting, at which the possible hazards of the experiment were
carefully considered. Following the discussion, the RAC voted in
each of the three cases to recommend approval.
Advice was also sought from the Department of Agriculture Re-
combinant DNA Research Committee, which in each o f the three
cases recommended a pprova l. And finally, NIH approved each ot
the threeljifbposals with a notice in the Federal Register.
The three approved cases are: approval to Dr. Ronald Davis, of
Stanford University, to field test corn plants transformed by corn
DNA; approval to Dr. John Sanford, of Cornell University, to field
test tomato and tobacco plants transformed with bacterial and
yeast DNA; and approval to Drs. Steven Lindow and Nickolas Pan-
opoulos of the University of California, Berkeley, to field-test bacte-
ria carrying deletions in the genes involved in ice nucleation. None
of these three approved field tests has actually been conducted to
date.
I NIH is not a regulatory agency and has iiQ_jstatiitQry authority
over ind ustry .. NIH's mission is the funding of research, and it has
authority to impose requirements only on those institutions which
accept NIH research funds. Most private companies do not receive
NIH funds and, therefore, are not required to comply with the NIH-
guidelines.
During the 95th Congress, in 1977 and 1978, 16 different bills
dealing with recombinant NDA were introduced. Bills which would
have made the NIH guidelines mandatory for the entire country
passed committees in both the House and Senate but never reached
the floor of the House or Senate for a vote. Th ere is therefore toda y
n o national law making t he N nLgl.iiHp1iriPs"rrLaruiatary tnr jirivatp
i ndustry. ~~ ~ ~~~
In the absence of national legislation, a number of localities have
passed local ordinances making the NIH guidelines mandatory. For
the rest of the country, other than these localities, for work not
>
supported by Federal funds, compliance with the NIH guidelines is
not mandatory.
There is, however, a section of the NIH guidelines entitled "Vol-
untary Compliance" which encourages commercial organizations to
comply voluntarily with the guidelines. At the last RAC meeting,
two proposals for field tests of genetically engineered organisms,
voluntarily submitted by private companies, were reviewed and
recommended for approval. A final NIH decision on these proposals
has not yet been made.
In September 1983, a lawsuit was filed by Jeremy Rifkin and
others charging violation of the National Environmental Policy
Act, and m May 1984, Judge John Sirica issued a preliminary in-
junction enjoining the NIH from approving deliberate release ex-
periments submitted by NIH grantee institutions, although specifi-
cally allowing NIH to approve such experiments voluntarily sub-
mitted by industry. The Government is appealing the preliminary
injunction. "^
In April 1984, the Cabinet Council on Natural Resources and En-
vironment Working Group on Biotechnology was established. It
consists of representatives of many Federal agencies. It is directed
to undertake a review of the Federal regulatory rules and proce-
dures relating to biotechnology, including a review of the function
of the NIH Recombinant DNA Advisory Committee.
This concludes my prepared testimony. I will be pleased to
answer any questions.
Senator Durenberger. Thank you very much. Dr. Talbot.
Dr. Moore.
STATEMENT OF DR. JOHN A. MOORE, ASSISTANT ADMINISTRA-
TOR, PESTICIDES AND TOXIC SUBSTANCES, ENVIRONMENTAL
PROTECTION AGENCY
Dr. Moore. Thank you. Senator Durenberger.
Biotechnology is the application of biological science towards
technological ends, such as the production or use of chemicals or
life forms for commercial or potentially commercial uses. Recent
developments in biological sciences have greatly enhanced scien-
tists ability to manipulate genetic material and to develop new
microorganisms, plants and animals. These advances are expected
to lead to the availability of a variety of useful products in a wide
range of industries, including chemical production, agriculture and
environmental protection. Commercial products of biotechnology
are expected to be available in the very near future.
As with any new process, there are questions about the human
health and environmental implications of developing and using
microorganisms for commercial purposes. Novel microorganisms,
whether they are nonindigenous or whether they are actually ge-
netically manipulated organisms, may be placed in ecosystems
where they have not existed before and where natural mechanisms
for controlling their populations may not exist.
To address these concerns, EPA is developing a regulatory frame-
work for reviewing certain commercial products of biotechnology
that would come under our jurisdiction and review before they are
intentionally released into the environment.
' ' / • ^ / / /■ 5 /"^ ' /' ^'^ ^
J We will be invoking our statutory authority to review and, where
ynecessary, regulate products intended for commercial use. We are
(^not intending to arbitrarily extend our authority to all products or
processes of biotechnology.
EPA intends to publish two Federal Register notices addressing
EPA's statutory authority and planned regulatory approaches in
this area. It is my understanding that other agencies that have reg-
ulatory authority in this field are also considering preparation of
such guidelines.
The first notice EPA is going to be issuing will be an interim
policy statement specifically dealing with the field testing of novel
microbial pesticides which EPA is addressing.
We define novel microbi al pesticide s to be those which contain
naturally occUfring microorganisms toF use in environments where '^/,
they are no fliatiy er of~microo r ganisms which have been_geneticar- u
l y altered or mam pulated^JbyLJi^mans.
"'This'interim policy wilT requlreanotification to EPA prior to all
small-scale field tests involving deliberate release into the environ-
ment. This notification will permit EPA to determine whether an
experimental use permit will be required before small-scale field
testing is conducted. This interim procedure will not apply to stud-
ies conducted in contained experimental facilities such as laborato-
ries, growth chambers, greenhouses or other facilities where there
Js^no deliberate release into the environment. This notification pro-
cedure will allow the agency to evaluate the potential risks of field
tests with only a minimum impact on the development of beneficial
novel microbial pesticides.
The second and more general Federal Register notice will discuss
the Agency's broad policy regarding the regulation of novel micro-
bial products under TSCA and FIFRA. This notice will clarify
EPA's regulatory authority over novel microbial pesticides and will
outline the agency's specific plans for reviewing and registering
these pesticides under FIFRA.
The notice will also discuss EPA's proposed policy for reviewing
novel microbial products under TSCA. In particular, EPA believes
that n ovel m icrobial products produced by recombinant DNA, cell
fusion,~or dtlTer~techniques'of"genetic engineering are new chemical
substances subject to the premanufacture notification require-
ments, unless they are substances such as drugs or pesticides that
are excluded by statute from TSCA regulation.
The agency also intends to address the applicability of TSCA re-
quirements to field tests or other research and development activi-
ties. The notice will provide an opportunity for public comment on
how the agency should apply these two statutes to novel organisms.
Although a large volume of comments is anticipated, we commit
ourselves to expeditiously review these comments and promulgate
the final policy quickly and prudently.
EPA's Office of Research and Development is conducting impor-
tant research in the area of biotechnology to address three impor-
tant issues: (1) The possible public health and environmental conse-
quences of the release of novel microorganisms into the open envi-
1 ronment; (2) the possible consequences associated with the increase
lof wastes and emissions from a growing biotechnology industry;
land (3) the application of biotechnology to improve the environ-
ment by degrading persistent and toxic chemicals to provide previ-
ously unavailable tools for monitoring pollutants.
ORD has already sponsored workshops consisting of scientific ex-
perts in this area from academia, industry and Government to
identify the major areas where knowledge is lacking and to define
further the Agency's research plan.
The consensus of these workshops is that considerable informa-
tion already exists which is relevant to the assessment of micro-
bials. The recommendations were that this information needs fur-
ther review and should be built upon in the future to address infor-
mation gaps and standard protocols that are currently unavailable.
To ensure that the workshop recommendations and EPA plans
are appropriately developed, a biotechnology research program
management team has been formed to coordinate activities within
ORD and to facilitate responses to regulatory office needs.
Obviously, a major issue in any regulation of genetically engi-
neered organisms is^he effect of Federal^yersight and regulation
JS^ i n inno va tion in what is a very promising industry. Innovation is
fikeljT toHSe^bf major economic importance to the U.S. economy and
to provide significant benefits to the public. Unnecessary or confus-
ing regulations will pose a serious problem to industry and may
give a competitive advantage to those in foreign countries.
The biotechnology field is in its infancy and our regulatory
framework must be flexible to allow the evolution of policies as
new knowledge becomes available. Thus, it is also essential that
the Federal Government coordinate its efforts in regulating this
new industry and ensure that any regulations imposed are neces-
sary, consistent, and appropriate.
As the subcommittee is aware, the Administration has formed an
ad hoc working group of the Cabinet Council on Natural Resources
and the Environment to address Federal regulation in this area
and to ensure a consistent overall approach. EPA is an active
member of the working group. EPA is also working closely with
other Federal agencies that share an interest in biotechnology, in-
cluding the National Institutes of Health and the Department of
Agriculture.
I believe that a coordinated Federal approach in this area involv-
ing all interested agencies will permit a highly successful biotech-
nology industry to exist in this country, while at the same time en-
suring protection of public health and the environment.
That concludes my statement, Mr. Chairman.
Senator Durenberger. Thank you, Jack.
Dr. Kendrick.
STATEMENT OF DR. EDGAR L. KENDRICK, ADMINISTRATOR.
OFFICE OF GRANTS AND PROGRAM SYSTEMS, DEPARTMENT
OF AGRICULTURE
Dr. Kendrick. Mr. Chairman, thank you for the opportunity to
testify on the role of the U.S. Department of Agriculture on the
subject of this hearing.
The Department of Agriculture has had responsibility since its
founding over a century ago to sponsor research and encourage the
application of this research for the betterment of the food, feed.
and fiber needs of the Nation, in both its national and internation-
al roles.
At its founding, the Department was also uniquely enjoined with
the land-grant university development and, as a result, the re-
search and application responsibility is fulfilled through State, Fed-
eral, and private cooperative efforts.
We believe this vast network of scientific expertise, laboratories
and controlled environmental facilities have indeed provided well
for the nation in the past, and with our careful planning and intro-
duction of the new biotechnology initiative, including genetic engi-
neering, we will be able to continue to serve the Nation in the
future.
I recognize that this subcommittee's immediate interest is in
what is commonly referred to as genetically engineered organisms,
and most especially wherein recombinant DNA technologies have
been utilized in plant, animal or microbial species, and deliberate
or intentional release of the improved species is desired. However,
as background, I think it is important to note that the agricultural
research community has had a long and highly successful history
of developing the genetic components of plant, animal and microbi;
al life for the benefit of society and its environment-broadly.
rSlI the major anim al and cr op speci es used for agr icu ltural pro-
duction in~S.merica today_h_ave.^en critically designed and deliber-
ately released. _ Also, millions of acres of trees are similarly ile-
signed to provide our fiber needs. In total, these food, feed and fiber
production processes involved deliberate release into the environ-
ment of billions of living organisms, each involving design and ma-
nipulation of their DNA components 'The corn crop alone this year
has been estimated to have 193x10^ '^ plants, or 193 trillion, each
with its own designed DNA components. Not only did the total ag-
ricultural mass of living organisms interact with existing orga-
nisms in the environment, it also withstood an array of natural
and manmade threats while contributing vastly to society's well-
being. Its complexity is staggering.
Recombinant DNA, and other closely related genetic engineering
policy issues, are addressed by the USDA Recombinant DNA Re-
search Committee, known as ARRC. Research in laboratories and
other controlled environments, as well as release into the environ-
ment broadly, is critically assessed. Each agency in the Department
that is directly concerned with recombinant DNA research and its
application and regulation is represented on our ARRC. In addi-
tion, the Director of the Office of Recombinant DNA Activities of
NIH, which administers the Recombinant DNA Advisory Commit-
tee, RAC, and the guidelines, is also a member of our committee.
Similarly, a National Science Foundation representative is also a
member of our committee.
Other research policy committees concerned with recombinant
DNA and the new biotechnology in agriculture include the Experi-
ment Station Committee on Organization and Policy, ESCOP, and
the Committee on Biotechnology of the National Association of
State Universities and Land Grand Colleges, NASULGC.
In the evaluation and review of research involving recombinant
DNA, including field experiments, the Institutional Biosafety Com-
mittees, IBC's, are an essential feature. This is so both in Federal,
8
State, private and industrial facilities. The IBC's are an essential
feature of the RAC and guideline processes.
At the earliest stages of development of RAC and the guidelines
for conducting recombinant DNA research, USDA scientists and
scientists from the agricultural research community broadly were
involved. Along with the scientific community, we have strongly
supported the concept of a set of standards and procedures for the
conduct of recombinant DNA research in the United States. We
remain highly supportive of RAC, and scientists from the agricul-
tural research community serve on the committee and on special
working groups constructed by the committee as needed. The
ARRC was designed to be complementary to the RAC processes and
is so utilized today. Projects and policy issues involving agricultural
interests are reviewed by ARRC on behalf of RAC and in further-
ance of the guidelines processes.
In the Department and in the scientific community we find in
place mechanisms that provide continual review and oversight of
research as new knowledge evolves. These mechanisms also provide
for special considerations warranted by genetically engineered or-
ganisms.
We highly applaud the RAC process. With a decade of experience
we find it has earned wide respect over the Nation and the world.
Concepts built into the processes early on provided for change as
knowledge overtime was acquired and attracted the highest levels
of expertise. A highly participatory process with a full range of ex-
pertise and interest all have contributed to its success. These check
and balance processes have assured that it is not self-serving, but
has addressed the needs of society broadly in this area.
Research projects that envision potential release into the envi-
ronment under controlled research conditions, or ultimately broad
release, have built into them at an early stage extensive study and
review of the molecular ecology involved. Furthermore, biological
containment and gene performance in increasingly complex envi-
ronments are tested under controlled conditions. Specific environ-
ments, genetic drift and gene wearing in mixed systems are tested
under controlled conditions. The multitude of naturally occurring
genetic accidents and the resulting potential for interaction, as
well as ecological gene training and attenuation, are similarly
tested.
Thus the resulting plant, animal, or microbial biota to be used in
agriculture, wherein recombinant DNA technologies have been em-
ployed in their development, are not inherently different_in_ nature
than those we ha ve u sed in the" pastrThese result ing products
shou ld" notn5e~tfea teg~difTerently:
"TirsumTnaTyvfKa^e- outlined the evaluation and oversight activi-
ties involving research and field experimentation with genetically
engineered organism.
This completes my statement. I will be pleased to answer any
questions.
Senator Durenberger. Thank you very much.
Jack Moore, you have been here more often than the other two,
so I will start with you.
The very fact EPA is spending a lot of time working on a regula-
tory program tells me that you think there is in fact a potential for
9
adverse environmental effects. I wonder if you would indicate to us
what you see these effects to be and what you will be looking for
when you review and experiment on the product.
Dr. Moore. Senator, let me respond by selecting a few things out
of the interim Federal Register notice which deals with novel mi-
crobial pesticides; this notice should be signed and available within
a few days.
/ Chemical pesticides have no independent mobility or reproduc-
tive capability. Microbial ^pesticides, on the otherJiandj_may_repli-
cate anjdLjBftafcrSpread beyond thejjJtEilflflappTica tions. As I men-
tioned in my opening statement, microbial pesticides may not be
subject to natural control or dissemination mechanisms. Therefore,
small-scale field studies with novel microbial pesticides can raise
many of the same concerns as the more extensive use of conven-
tional chemical pesticides raises. This is why we want to get at
them early. I think it also intimates as to what is the nature of
some of the concerns that we have.
At present, there is a high degree of uncertainty in predicting
the ecological impacts of releasing the microbial pesticides into the
environment. For example, novel microbial pesticides could exhibit
increased competitiveness, a greater ability to survive, broader host
I range, enhanced virulence, compared to the indigenous microbes,
*^r its introduction could lead to ecological perturbalions.
Because microorganisms can reproduce and be disseminated by a
variety of different mechanisms, theyrnay be difficult to controLpx
eradi cate aft e r be ing introduced. Therefore, I think what we are
looking for in the way oTevaluaiting such material before it gets
into the environment, even under an experimental use permit for
pesticides, is "Will it stay where it is going to be put?" Is it host
specific — obivously a pesticide is developed to do something that we
think is desirable — what else might it do or, indeed, is it only going
to do that which is intended? How long will it remain in the plant
or soil, or whatever the case may be? It is these types of activities
we are interested in.
We are also interested as to whether or not it can cross-infect or
trade, if you will, some of its new genetic information with indige-
nous plants. We are trying to identify the need for test data and
approaches to test data that will give us information so one can
make an informed opinion as to whether or not one wants to go
ahead with the uses.
Senator Durenberger. Dr. Kendrick, I always hate to character-
ize people's testimony, but you seem to be saying that the new ge-
netic engineering technologies aren't really the science fiction that
I referred to in my opening statement, nor especially exotic, but
just another example of the genetic manipulation that has been
going on in agriculture for a long time. Do I understand that to be
an accurate characterization?
Dr. Kendrick. That would be accurate.
Senator Durenberger. Let me then read to you a few lines from
a recent issue of Omni magazine.
Using a new heat-shock process, Barry McDonald and William Wimpey have
fused cow cells with cells from a tomato plant, creating a typical-looking tomato
plant with tough, leatherlike skin.
10
According to A. DeMaggio, a plant development physiologist at Dartmouth Col-
lege, this type of work is going on in several laboratories around the world.
McDonald and Wimpey, encouraged by their initial success, have embarked on a
new project, aimed at producing a tomato-wheat-cow superhybrid. With the soaring
costs of raising cattle, the researchers hope to develop an easily grown, protein-rich
"planffor production on "wheat ranches."
I am just wondering if that sounds to you like traditional breed-
ing practices.
Does the USDA review system contemplate an ability to handle
research of this type?
Dr. Kendrick. Yes, I believe we could. What you have cited is an
ability, in my opinion, of a technology that now allows scientists to
go in and extract specific genes and insert them in the organism
that they want to, for improvement of that organism.
Triticales is a product of wheat and rye, two species that do not
cross naturally. However, through genetic manipulation, mutagene-
sis, and so forth we came up with a product of these two species,
Triticales.
So I believe that is not the traditional breeding that you cited;
but there are going to be desirable genes in other organisms that
do not naturally cross, that will be investigated and inserted into
certain organisms for their improvement.
What I am saying is we have a system; we have people who un-
derstand all those specific organisms and can follow and, test them
responsibly.
Senator Durenberger. Why don't you give us, without a lot of
detail, a brief explanation of how you have changed the people in
the technical capacity within USDA to handle this somewhat dif-
ferent research.
Dr. Kendrick. I am not sure that we have. If I understand your
question, Senator, how we changed the ability?
Senator Durenberger. Even I can understand tomatoes and
wheat, but when you start adding cows and some of these other
things, it strikes me that perhaps some of the scientific expertise
that you might require to do a review system might change. I am
wondering about the degree to which you have changed that capac-
ity in terms of personnel.
Dr. Kendrick. I think we have the existing scientific expertise
on board and accessible to us, through the vast land grant system
and the Agricultural Research Service. We can go to these people. I
believe that the Institutional Biosafety Committees that I men-
tioned would be operative in overseeing the kind of research that
you just cited. They would first review that kind of research, if it
had not previously come to the RAC. Thus, there would be some
people that are very broadly knowledgeable, as the people are who
serve on the RAC, who would be looking at that experiment before
it was ever carried out.
Senator Durenberger. I am given to understand, and I have no
independent means of verifying this, that a lot of the new genetic
engineering biotechnology companies that are rising have arisen
from the genius of, among others, land grant university scientists
who either deliberately or accidentally stumbled across a variety of
new opportunities, and they sort of spin themselves out of a low-
11
paying environment into an opportunity that all of us, of course,
may envy.
Do you see in your reliance on university-based research and
review any potential conflict with the USDA review process? Obvi-
ously w hat I am getting at is the question that is alwavs rais ed
with regard to U^DA: Is it in the promotion business or what busi-
ness is it really i n; and to what degree, if we are looking at this in
terms of societal safeguards, can we rely upon the USDA revi ew
process?
Ur. Kendrick. Our committee in agriculture is very heavily sci-
ence based. At the recent Biotech 84 conference, I think this very
issue came up, about all the experts are going to be over there in
the biotech industry where perhaps the greater opportunities are
for reward and the like.
I think the academic community feels this as do some of the
people who are now practicing biotech in industry, that there are
going to be those people who would rather remain in academia and
who will continue to serve on committees like the RAC and who
will be accessible to our agriculture committees. So we think it will
continue to be not a self-serving process.
1 know what you are referring to, that we will be looking out
strictly for the interests of agriculture. But our committee is trying
to make its decisions based on good science.
Senator Durenberger. The traditional process is, as a new in-
dustry develops, it calls upon some very talented people from uni-
versities, for example, in a consultant capacity to advise these
emerging industries.
To what degree, or maybe it is too early to tell, are some of these
consultants that are used by you in your review process also used
by some in the promotion of product development in the private
sector?
Dr. Kendrick. There are many of them, as you have indicate(^V^
that are serving in the dual roles: remaining with the academic J^
community and in a consulting role with the industry.
In our review process we, of course, will try to not rely too heavi-
ly on that person who has the dual association because we recog-
nize we are a public agency. So there doesn't appear to be that con-
flict of interest, we will try to rely primarily on those who are the
pure academic types. I believe there will continue to be some of
those. Also I believe we will want to work with those people out in
the industry who are at the forefront of what is going on and we
will want to have some exchange with them. We will not rely on
them that heavily or totally in the review process.
Senator Durenberger. Dr. Talbot, you point out in your testimo-
ny that private industry does not have to submit release experi-
ments to RAC. That is a correct statement of your testimony, is it
not?
Dr. Talbot. Yes.
Senator Durenberger. As your testimony indicates also, two or
three companies have done so. I think the first three were volun-
tary submissions. The committee recommended approval of all
three. I am not clear whether the Director of NIH has acted on any
of them.
12
Dr. Talbot. We have had numerous submissions from private
companies in other areas than for deliberate release to the environ-
ment. But my testimony concentrated on deliberate release to the
environment of organisms containing recombinant DNA. In that
area, NIH has approved three proposals, all of which came from
academic institutions which are required to submit because they
are receiving, their academic organizations, NIH funds for recombi-
nant DNA research. That is Cornell University, the University of
California at Berkeley, and Stanford University.
At the last RAC meeting the RCA Committee took up two pro-
posals voluntarily submitted from private companies for deliberate
release to the environment of organisms containing recombinant
DNA. NIH has not yet made a decision on those.
In other areas not dealing with deliberate release there have
been numerous submissions from private companies and numerous
questions from private companies asking for interpretations of the
Guidelines and registering their local Institutional Biosafety Com-
mittees with us and checking if they meet the criteria of the Guide-
lines.
Senator Durenberger. Is there any Federal law or regulation
that would prevent companies that may have submitted voluntari-
ly but who get tired of waiting for the Director to make a decision
to just go ahead with their experiment?
Dr. Talbot. There is no law or regulation prohibiting them from
going ahead if they get tired of waiting.
Senator Durenberger. I heard reports that one of the three vol-
untary submissions has made inquiries of the Canadian Govern-
ment about performing the experiment in Canada instead of the
United States. Do you know anything about that?
Dr. Talbot. I have heard that third hand and not directly. I have
not verified that directly.
Senator Durenberger. You mentioned one limitation of the NIH
guidelines, that they have no regulatory force over many of the ex-
periments that may be of concern. Isn't there also a second lim ita-
t ion, that vour gniHplinps applv only to recombinant UJNA ex peri-
Jlf^ ments. not to fusion or ot.hpr forms of genetic manipulat ion?
Dr. Talbot. That is correct.
Senator Durenberger. Dr. Kendrick, you mentioned a number
of review safeguards that are applied to genetic engineering which
left me with the impression that each release experiment is thor-
oughly scrutinized before it is carried out. Do private genetic engi-
neering companies have to get a USDA clearance through this
review process before they carry out a release experiment?
Dr. Kendrick. No; they do not have to get a permit from the
USDA.
Senator Durenberger. So then who is subject to the review proc-
ess?
Dr. Kendrick. So far we have been implementing the recombi-
nant DNA guidelines, and all of our people in the Federal Govern-
ment, all Federal research scientists, must adhere to those recombi-
nant DNA guidelines, also anybody who has a cooperative agree-
ment with us through some Federal funding.
Let me give you an example. We are working through these
things right now with regard to our existing regulations, which are
13
housed primarily in the Animal and Plant Health Inspection Serv-
ice. We are working through how we would handle these things
that are coming about by means other than recombinant DNA to
see whether we would need to modify the existing regulations.
Let's say Pioneer Hybrid wants to release a new corn plant that
has a new resistance capacity which was achieved through other
than recombinant DNA technology. If it had been recombinant
DNA, it may or may not have come through the RAC.
Before Pioneer can put that new variety out on the market, it
will be extensively tested. They will put it into the land grant test-
ing system voluntarily. They always have and they will continue to
do so, to see how it tests out against existing varieties. They will
want the public sector to test that.
That is an experimental and a somewhat confined and controlled
test. Then, before they release that variety in the State where they
want to market it, they are going to have to deal with the regula-
tory authorities of that State. So it gets some sort of test and close
scrutiny, along the way. They will have to identify what is new and
novel, about that variety compared to some other varities that are
in production. They will have to reveal to some extent, how did
they arrive at that new genetic type.
Senator Durenberger. Is voluntarism in the area which Agricul-
ture would be most concerned with — maybe you could just describe
for us the traditional nature of voluntarism in complying particu-
larly with some new Federal standards, or even if there aren't Fed-
eral standards or regulatory requirements. Is there a tradition of
voluntarism on the part of the seed industry? You used Pioneer as
an example. Are there some special reasons why in order to
market a product against competition, or whatever, that you can
have a degree of reliance on voluntarism in that particular part of
the industry?
Dr. Kendrick. Yes; I believe you described it right. There is a
traditional and historical voluntarism. If they want to market that
product, they will run it through the evaluation system that we
have traditionally followed in agriculture, be it private industry or
a public released variety. So pretty much in the seed industry I
would say yes, it has been voluntary and will continue to be so.
Senator Durenberger. I don't know whether you are the person
to answer this question, but I assume that to a degree either volun-
tarism or something else as you might characterize it has been true
in the area of pesticides and insecticides for a long period of time.
And to date, at least in the last year or so, we have found some
reason to be concerned, not about the nature of the approval proc-
ess or the regulatory requirement but the results of that process.
In other words, the impetus, obviously, is on expanding produc-
tion by limiting the adverse effects of pests and insects and so
forth. So, at least as I recall from our series of walking through the
fields of ethylene dibromide, it looks like it is not a very complicat-
ed process to get USDA on your side, as you are marketing to
farmers all over this country those kinds of new products that will
increase their production in one way or another.
Have you seen that process change in the last year or so? Have
you seen the attitude, if you will, on the part of the private sector
industry toward the adequacy of the governmental processes to
39-383 O— 84-
14
react appropriately to the environmental concerns that their prod-
ucts might present? If you have, I wonder if you would share with
us the nature of that change.
Dr. Kendrick. Jack Moore, I am sure, may also have a comment
on whether this attitude or willingness on the part of industry has
changed with regard to testing pesticides, etc.
Let me say at the outset we fully recognize the role of EPA in
the regulation of pesticides. We are not in the business to regulate
pesticides in the Department of Agriculture, but we are involved in
a lot of the experimentation and testing up to the time they are
ready or being put out as a product.
Also, I would like to comment on your term, that we are trying
to do these things to expand production; not necessarily to expand
production. In fact, primarily, we see these tools that are in our
hands right now, as giving us a great opportunity to increase pro-
ductivity. Productivity means reducing farmers costs by using
fewer pesticides which also helps reduce pollution. The benefit is
there when he doesn't have to apply the expensive nine pesticide
treatments. In other words, come up with new resistance, come up
with a new way of controlling the gypsy moth or pests like this
where you don't have to use the pesticides but rather use some
means of biological control.
I want to make it clear that we are not looking only for ways to
expand production. Production is not a real problem for us right
now, as you well know.
Senator Durenberger. You mean 193 trillion corn plants is how
many too many?
Dr. Kendrick. You know, we had a shortage not too long ago.
There will be people who will tell you we will have more shortages.
So it is that ability, that capacity to produce that is important. We
must continue to improve our ability to market this production.
Senator Durenberger. I clearly agree with you that maybe pro-
ductivity is the better word. It is certainly appropriate if we are
ever going to develop an agricultural policy in this country. If we
restrain the expansion of the land base under that production, that
we put much more of an emphasis on natural resource conserva-
tion, and that should logically lead you to get greater productivity
out of a smaller natural resource base, which again brings me
around to expressing my concern, as I have in these other ques-
tions, about the role that USDA plays in promoting productivity
then will play in any kind of a review process that will substantial-
ly increase that productivity.
Dr. Kendrick. I didn't directly answer your question about do I
see an improvement or change in the private industry with regard
to their wanting to test and evaluate these products. I believe yes,
there is an awareness and a real sincere effort on their part to test
more thoroughly than ever before.
Also, let me say that we in USDA recognize there are some
people out there who see this as a real unknown, kind of a scary
area, because we have these tools now and the ability to genetically
engineer. What we want to convey, and we are in the process of
trying to do a better job of that than we have done, is that we have
been genetically manipulating plants, animals, and microorganisnis
for years in a less precise manner than we are able to do now. It is
15
happening in nature every day, and we have a lot of people that
have followed that process very closely; people who work on noth-
ing but one type of bacterium, one species of bacterium, and who
are pretty knowledgeable of all of the variants that exist in that
bacterium. They have studied its ecology. They can predict pretty
well what will happen with that organism.
So we want to assure people of this evaluation and testing proce-
dure that we have followed for years and convey to them that we
really don't see any great danger. However, we recognize it is an
unknown to some people right now. Thus, we are in the process of
trying to more clearly articulate our rules and regulations, our
oversight.
We want to work with the EPA and the NIH in their roles. We
think we will do a better total job that way.
Senator Durenberger. Jack, I wonder if you would add a dimen-
sion from your point of view to the question I raised relative to the
private sector. It seems to me that in the last 6 or 8 months, the
food processors are pretty dissatisfied with the way we in govern-
ment, over the years, have approached this whole business of envi-
ronmental safeguards when we in effect put our good government
seal of approval on these products.
It seems to me that they are looking to us now, particularly as
we enter into an exciting new field, for some clear guidance and
sense of direction before we encourage another industry to improve
the quality of our life.
I wonder if you might just react to that change, if, in fact, it
exists out there.
Dr. Moore. I might make two comments. My perception is simi-
lar to yours as it relates to the food process ing industry. That is
/ that in the last 6 or 8 months, they^ certainly "have developed a very
/ keen interest and awareness as to what EPA might be doing or
/ might not be doing in the area of pesticides as it might relate to
V their ability to do business.
This awareness I think is a very productive one as opposed to
being an adversarial type of relationship. They have had discus-
sions with us, for example, as to what are we planning to do in the
interim? How might they help us? What data do they have that
might allow us to make a more informed judgment on something
that is a prospect?
The other aspect, and I am not sure this reflects any rapid
change in perspective — it might reflect a learning curve on my
part — is the farm user, if you will, of pesticides certainly has a
broader perception of what he or she wants to do than maybe I was
willing to give them credit for. They are certainly aware of the
need for integrated pest management or the need for other types of
practices which might reduce their reliance on chemical pesticides
of one sort or another. One, because of cost; but I think even cost
aside, the other thing that strikes me is that they are fairly well up
and abreast on integrated pest management: for example, that
there are alternative ways that they might be able to achieve some
of their ends which allows them to reserve or preserve, if you will,
the effectiveness of the pesticide.
No longer, I think, are you seeing farmers routinely using a pes-
ticide over and over again. I think they would much rather use it
16
mors as a scalpel type of approach as opposed to the shotgun type
approach. So, I think they have learned from looking at the pesti-
cides that first came on the market, where resistance developed
tor example, where it was no longer available to them, not neces-
sarily because the government took it away from them, but it just
wasn t effective They find if they can mix their pesticide control in
one way or another, they are better off in the long run
Senator Durenberger. You indicated in your testimony, Jack
that the testing requirements will allow the Agency to evaluate the
potential risks of field tests with only a minimum impact on the
development of beneficial novel microbial pesticides.
I wonder if you would elaborate on that.
Dr. Moore. Yes; section 5 of TSCA exempts new chemical sub-
stances that are produced in small quantities solely for the pur-
poses of research and development. In looking at that approach as
It relates to biotechnology and the development of microbial pesti-
cides, there may be a need for us to better define by rule what we
mean by small quantities and, indeed, the possibility might be to
take out from this PMN notice exemption microbial pesticides that
are destined for environmental penetrants as a part of their R&D
process, again falling on the logic that if you don't, there, indeed
may be an adverse effect where none was anticipated, and it won't
be captured by the PMN process.
Senator Durenberger. Part of the problem is distinguishing
from the purpose, whether it is R«&D or being manufactured for
commercial purposes. Can you address that by rule or would it be
Tu P-.^ o^*' ^^ ^^ approach TSCA amendments, we clarify that au-
thority?
Dr. Moore OurjairrenUe eling is that we ought to try to see if
we can do it by rule. I donTSrecloae th e n epdJmLjjQiiibiriputo-
rv assistance. But right now we have some degree ofconHdence
Tjp T^ r?^ from the standpoint of somebody who is undertaking
/an K&U ettort for commercial purposes, we might be able to close
/ that exclusion by saying that novel microbial products are excluded
\from this R«&D exemption.
Senator Durenberger. Your testimony also notes problems that
Z might arise from release of genetically manipulated organisms.
Yet, some people argue that making genetic changes in native or-
ganisms is not risky, at least not as risky as introducing a nonindi-
genous or exotic organism.
Is EPA going to make any distinction between native species and
exotic species where genetic engineering is concerned, or do you
think such a distinction even warranted?
Dr. Moore. No; I think we are looking to apply to TSCA the
same logic we have applied to FIFRA. That is, a novel microbial in
this case is not necessarily one that was created just through genet-
ic manipulation but, indeed, might also be one created by finding
something that was 'natural' in its occurrence and putting it in an
unnatural place.
Before one allows that, if that unnatural place is out in the envi-
ronment, I think again we need to have some sense of what are the
normal controls that are out there that might make sure this thing
does what it js intended to do and doesn^t do anything we don't
want it to do.
17
Senator Durenberger. On the subject of the Cabinet Council
that all three of you referred to; how is this particular biotechnol-
ogy subcommittee being staffed?
Dr. Moore. Participation by a wide variety of agencies. I am not
sure I could list them all.
Senator Durenberger. Is there a lead to the process? Just tell us
something about how it is operating or going to operate.
Dr. Moore. The work group is chaired by OSTP. Jay Keyworth is
chairing the effort.
One of the first things that has been done is there has been a
collation of all of the statutes that have some bearing on biotech-
nology and an analysis on the basis of the feeling on the part of the
respective agencies of how their particular statute may be appro-
priate and how they are using it or plan to use it.
There is an intent I believe this fall to publish that in the Feder-
al Register, which would help other communities in general to
know who has what role under what circumstances.
Also, in the process of doing this, one underscores, if you will,
areas of overlap which should be reconciled prospectively, as well
as gaps that should be discussed.
I think the more important thing we are also trying to do in that
effort is to see if indeed one can come up with a general approach
which a number of the agencies can utilize rather than each of us
going off, such as little fiefdoms might do, and recreate the wheel
over and over again, which I don't think benefits anyone.
Senator Durenberger. I take it. Dr. Talbot, that you are com-
fortable that others representing the Government are now getting
into this area and looking at it from a variety of more appropriate
standpoints.
Dr. Talbot. Very much so.
Senator Durenberger. I also get the impression, given the basic
charge of NIH and the vital function that it has to play in our soci-
ety, that you probably wouldn't mind being relieved of the sort of
quasi-regulatory role in which you have found yourself, at least in-
sofar as it relates to environmental release; is that correct?
Dr. Talbot. I think there are many at NIH who would look for-
ward to our getting out of some of these roles we played. The Cabi-
net Council Working Group is looking at this and will be presum-
ably coming up with a plan that Jack Moore has alluded to which
would perhaps take certain functions away from NIH, or perhaps
even add additional functions to NIH. Until they have reached a
conclusion as to the overall need for a risk assessment strategy for
the whole Government, we are not really sure what that biotech-
nology working group will come up with.
Senator Durenberger. Thank you all very much for your testi-
mony. I appreciate it a great deal.
Our second panel is Dr. Alexander MacLachlan, director, of cen-
tral research and development department, E.I. du Pont de Ne-
mours; Dr. Martin Alexander, professor, department of agronomy,
Cornell University; and Dr. Winston Brill, vice president, research
and development, Agracetus Corp.
Gentlemen, we appreciate your being here and your patience
through the last hour. As I indicated to the other witnesses, your
statements, which we appreciate your preparing in advance, will be
18
made a part of the hearing record in full and we would appreciate
your summarizing.
We will ask you, as we have asked the other witnesses, to keep
your terminology to understandable for the generously called lay-
persons at this table. Please limit it to 10 minutes in summary.
We will start with Dr. MacLachlan.
STATEMENT OF DR. ALEXANDER MacLACHLAN, DIRECTOR, CEN-
TRAL RESEARCH AND DEVELOPMENT DEPARTMENT, E.L DU
PONT DE NEMOURS
Dr. MacLachlan. Good morning. I am Dr. Alexander MacLach-
lan, director of central research and development department, du
Pont. This department does most of the long-range basic research
for the company and also introduces new technologies. One of the
most important at the present time is biotechnology. My remarks
will deal with du Pont's involvement in the new biotechnology and
our views on how the Government should regulate it.
As you know, I have submitted a longer statement which should
be made part of the record. This is just a summary.
For clarity, let me define what I mean by biotechnology. Biotech-
nology is the directed molecular restructuring of genetic material
often referred to as genetic engineering. This test-tube splicing of
DNA and its introduction into cells is in direct contrast to more
traditional ways of moving genetic material around, such as plant
and animal breeding.
From a business point of view, du Pont already has a major stake
in the life sciences where biotechnology will make its greatest
impact. Although we have life sciences related sales at a level of
about $2 billion in pharmaceuticals, radio pharmaceuticals, x-ray
products, diagnostics, and agrichemicals, we do not yet sell any ge-
netically engineered products.
However, at du Pont over the past 5 years we have invested over
$150 million in new facilities, a large portion of which supports our
research in the new biotechnology. Through biotechnology we seek
understanding of disease and plant processes that we hope will
lead to improved pharmaceuticals, diagnostics, and agrichemicals.
These new products may be based on conventional chemicals or be
derived or manufactured by processes based on biotechnology.
By any measure, du Pont has a major stake in biotechnology.
But we are certainly not alone. Such commitments have been made
broadly by American industrial concerns both large and small. The
magnitude of this commitment combined with a scientific base
second to none in our universities has given the United States its
present leadership in the development of this new technology.
With this as background, let me summarize our views on Govern-
ment regulation.
First, we believe that regulations governing the introduction into
the environment of genetically engineered products, and their man-
ufacture and distribution, are inevitable and should be implement-
ed.
Second, as the regulations are implemented, it is important to
distinguish between control of science and the regulation of prod-
ucts. Basic laboratory science should not be controlled beyond the
19
precedents established by the National Institutes of Health Recom-
binant DNA Advisory Committee, called RAC for short.
RAC has worked well. Its case-by-case examination by acknowl-
edged experts is a sound basis of ensuring public and environmen-
tal safety.
While RAC guidelines are adequate for basic research, RAC does
not have the resources to oversee the development of biotechnology
products. Today, product developments arising from biotechnology
have no clear regulatory oversight agency. We should not leave
this vital new industry in such a limbo where laws and regulations
developed for other purposes will be applied wihtout any under-
standing of the technology involved.
We believe this must be corrected at the earliest possible
moment, and we believe that it can and should be done by existing
Government agencies; specifically, the FDA, the EPA, the USDA,
and OSHA. Several of these agencies believe that existing law gives
them such authority, and we see no reason to challenge this.
What we do suggest is that there be a systematic coordination of
regulatory oversight authority among these agencies. This coordi-
nation should involve several activities. Let me summarize what
we believe they should be.
First, there should be a clear expression of jurisdiction by the in-
volved agencies. Otherwise there may soon be a confusing array of
overlapping regulations both at the Federal and State level.
Second, the agencies should establish guidelines based on the
latest scientific information. This would form a consistent basis for
administrative regulatory oversight. To do this the agencies must
develop scientific competence in biotechnology. Until this is accom-
plished RAC should be consulted.
Third, we recommend establishment of an interagency commit-
tee for biotechnology regulation assessment. This committee would
serve as a sounding board for those regulated as well as environ-
mental and other citizens' groups and would be in a position to cor-
rect redundancies. This committee should exist for a finite term
and only be appointed to another term if need dictates.
Fourth, we recommend that an eminent individual with broad
background in biotechnology be appointed special counselor to the
President for biotechnology. Such an office would ensure that
emerging needs of this dynamic new technology are heard at the
highest levels of Government.
Finally, there should be a strong commitment to retain RAC to
continue to oversee laboratory research. RAC proceedings repre-
sent an important intellectual and scientific resource, and as new
regulations are proposed, it would be unwise to part from its coun-
sel.
In closing, we believe biotechnology will and should be regulated.
We believe this should be done at the Federal level and we urge
that the agencies involved clarify their oversight responsibility at
the earliest time. We also urge that regulations be formulated with
the continuing counsel of those at the leading edge of this technolo-
gy. If we do this right and devise realistic and enlightened rules,
we will give the public the best chance to benefit from this marvel-
ous new technology.
Senator Durenberger. Thank you very much.
20
Dr. Alexander, you're next.
STATEMENT OF DR. MARTIN ALEXANDER, PROFESSOR,
DEPARTMENT OF AGRONOMY, CORNELL UNIVERSITY
Dr. Alexander. Mr. Chairman, I will shorten my lengthy writ-
ten transcript given the constraints of time.
The introduction of a radically new technology usually will have
a number of uncertainties associated with it. This probably has
been true of every markedly new technology, whether it was the
use of fire by primitive societies, the industrial revolution, or the
application of nuclear energy to peaceful pursuits.
The proponents of these technologies, probably in the past and
certainly at present, argue for the enormous potential benefits and
the absence of uncertainties. These proponents are undoubtedly
among the best spokesmen for the benefits; it is their field.
[owever, i t does not necessarily follo w_t h a t th o sp thnt kno\v a
technology can also assess, it s risk. These individuals unders tand
t h'eir technology anHTiaye much to offer to societv bv exploiting it ^
but one should clearly distinguish their knowledge of how to make
use of a particular technology and the information needed to assess
the risks from what they plan to do.
For the environmental scientist, which I am, there is a high
degree of uncertainty in anticipatin gjbh e consequences of gene tic
engineering. U ncertainty is not equivalent to a beliet that there is,
Cr will very soon be, a problem, but it is associated with a feeling
that we are progressing along a course of action that may lead to
minor or major problems in the near or in the long term.
If genetic engineering is indeed the wonderful technology that
many of us believe, it will be used in ever more numerous ways,
and the various approaches currently being developed will be ex-
panded to include a variety of organisms, uses, and environments.
It has been stated frequently that no problems have arisen with
the few techniques and few organisms that have been engineered
to date, but the ever-expanding scope of genetics and the new areas
for practical exploitation will take us far beyond these few tech-
niques and these few organisms.
In this light, I, as an ecologist, am not too bothered by the lack of
information on the possible environmental consequences of the still
infant field of genetic engineering. However, I am enormously con-
cerned by the lack of a meaningful base of information to predict
what might occur as the science develops and industry becomes
able to transfer an increasing amount of genetic information from
one of many organisms to a variety of other organisms,
r^ It is the ever-growing number of organisms and the diversity of
i techniques that will be used in genetic engineering that increase
</_ the concern about our uncertainties and our lack of information.
^ Natural environments have a variety of checks and balances that
prevent the many species and populations in our surroundings
from being overly abundant or doing major harm to other species.
It is these very interactions that prevent most organisms from one
habitat from becoming established in another.
These same mechanisms probably will destroy most of the engi-
neered organisms that are deliberately introduced, just as they
/
21
have eliminated most organisms that are transported from one en-
vironment to another. Because of these natural checks and bal-
ances, environmental upsets associated with newly arrived or rare
organisms are uncommon.
However, these ecological upsets do occur. They take place under
two circumstances. First, when the natural system of checks and
balances is disturbed. This system of checks and balances can be
perturbed, and much attention has been given to the reasons.
Second, when species not previously present in an environment
are introduced into that environment. The establishment of the so-
called exotic species is known to have occurred for sparrows and
many other birds, the rat and mongoose among mammals, the
gypsy moth and many other types of insects, a host of plant species
that are commonly called weeds, and microorganisms that cause
major diseases of agricultural crops, trees, animals, and even of
humans.
Although one might question the applicability to genetic engi-
neering of our knowledge of the harm done by exotic species, that
information is much more useful than untested and often uncon-
vincing hypotheses about the lack of establishment or effect of an
organism whose behavior in nature is totally unknown.
Ecologists are embarrassed to admit that they cannot predict
whether a currently existing species will or will not become estab-
lished when introduced into a new environment. If ecologists
cannot make accurate predictions for existing organisms in a prob-
lem area that is ecological, how can a nonecologist make a convinc-
ing statement about a newly modified organism, one for which
there is no environmental experience?
What should we know in order to reduce the level of uncertainty
arising from the planned, deliberate release of engineered orga-
nisms? Five areas of ignorance stand out.
First, will the engineered organism survive? Obviously if it does
not survive, it will pose no hazard. But likewise, a nonsurvivor
would be of little practical interest to industry because it would
have little market value.
Second, will the organism multiply? For many species, the few
individuals that endure do not constitute a problem in agriculture,
ecology or public health, but should they multiply and reach large
populations, major disturbances become evident.
Third, is the potentially deleterious genetic information trans-
ferred from the deliberately released organism to other species?
The organism that is released may not endure, but those traits that
serve as the bases for concern might be passed to another organism
in the same environment.
Fourth, is the engineered organism transported or disseminated
to new sites? Many microorganisms and plants fail to be transport-
ed for any distance, but other species are widely dispersed and soon
appear at considerable distances from the point of their first intro-
duction. Witness at the moment the organism causing citrus
canker, which is not engineered, but it is suddenly appearing
where we could not predict.
Fifth, will the introduced organism have a deleterious effect?
This, of course, is the critical question. It is my belief that most ge-
netically engineered organisms will not pose problems because
22
most will not survive, most that survive will not multiply, gene
tr ansfer is reasonably infrequen t, most that survive and multiply
will not be transported to a distant place, or most transported orga-
nisms will not have the traits needed to cause injury. The fact that
most engineered organisms will fail one of these tests does not
mean that all will. Which organisms will fail one or more of these
environmental tests cannot now be predicted.
Indeed, our knowledge is so limited that it is not even possible to
state the characteristics that result in failure or success. Large un-
certainties exist in anticipating the environmental consequences of
genetic engineering because of these major knowledge gaps, gaps in
the subjects of survival, multiplication, gene transfer and dissemi-
nation.
Can we even predict the potential of novel organisms for doing
harm? The information on ecological upsets and on diseases of
plants, animals and humans is abundant. Enormous numbers of
human deaths have resulted from the introduction of microorga-
nisms into regions where the people were not previously exposed to
the harmful agent, and the decimation of the population of Indians
in North and South America and of the original inhabitants of the
Pacific islands bears witness to the susceptibility of previously un-
exposed populations. The responsible microorganisms were not de-
liberately modified genetically, but simple genetic changes that
have occurred and do still occur in nature have been the prelude to
major human diseases. These genetic changes may not be too dif-
ferent from those that are currently of interest in genetic engineer-
ing.
In addition, agricultural crops have often been devastated follow-
ing the introduction of a new disease agent, and many of these dis-
ease-producing microorganisms are genetically very similar to spe-
cies that previously had little effect.
As I have said, it is my belief that the probabilities of survival,
multiplication, gene transfer, dispersal and detrimental effects are
quite small and, therefore, the probability of the final event in the
sequence is even smaller. Nevertheless, I do not know how small is
a small probability.
Moreover, as genetic engineering uses new techniques, is applied
to more organisms and is more widely used, an event that may
take place one time in a thousand will occur because the type of
event has been repeated 1,000 times.
Let me stress what I believe is a crucial point: In the absence of
a substantive body of scientific information to allow for reliable
predictions, and in the absence of data from tests designed to pro-
vide information on individual genetically engineered organisms, it
is utterly foolhardy to anticipate what may or may not happen in
rlature.
Scientists notwithstanding, uncertainties will remain even as we
gain more information, but at least the degree of uncertainty and
presumably the likelihood of a problem arising will be substantial-
ly reduced as the information is obtained.
The degree of uncertainty can also be reduced by data from ap-
propriate tests mandated by a regulatory agency. Even with a
wealth of scientific data, testing is important because science pro-
vides generalizations, guidelines and approaches, but exceptions to
23
the rule are not exceptional. Science can reduce but surely not
eliminate the uncertainty. Hen ce, it is esse ntial <'^a<^ « rpgnlafnry
agency require a meanine^ul but not one rmis- series -of-tests to
e valu ate potential hazards.
I am excited by^the prospects and benefits of genetic engineering.
I am also impressed by how little we know of the potential behav-
ior of deliberately introduced organisms. I believe that the consid- \
erable uncertainties that remain among environmental scientists j
can be reduced very markedly. This can be accomplished by re- 1
search designed to predict the behavior of novel organisms and by /
regulations that require industry to provide information to allow /
for assessment of safety or hazard. In this way, I believe that we/
shall be able to gain the benefits of an extremely important new/
technology while minimizing the risk to humans, agriculture and/
our environment.
Thank you.
Senator Durenberger. Thank you very much.
Dr. Brill.
STATEMENT OF DR. WINSTON BRILL, VICE PRESIDENT,
RESEARCH AND DEVELOPMENT, AGRACETUS CORP.
Dr. Brill. If there is one message I leave with you today, it is
th at there is no re ason to believe that use of a genetically eng i-
nee red plant, bacterium or tungus to be created in the foreseeable
futur e will in any way be any less safe than those agric ultmal
p ractices and products in common and widespread use m the world
today^ I'his conclusion is based on our actual experience as a socie-
ty with current and historical agricultural practices. This conclu-
sion is supported in detail in my written testimony, but I think it is
helpful if I emphasize its most important points here.
This is mid western corn. To make this plant even more valuable,
corn breeders continually look for new gene sources and try to
make valuable hybrids between this plant and others. These breed-
ing practices over many decades have had a major positive impact
on U.S. agriculture.
This is teosinte, a Central American wild grass which is now pre-
sumed to be the ancestor of our modern corn. Scientists around the
world have been crossbreeding corn lines with teosinte in order to
introduce new genes into corn; for instance, to achieve better dis-
ease resistance in corn.
Thousands of such hybrid crosses are performed in fields in this
country and others. When these two plants are crossbred, they mix
all of their hundreds of thousands of genes randomly to yield prog-
eny with a wide spectrum of genetic characteristics. These cross-
breedings would not occur without man's intervention, and the
characteristics of these progeny are impossible to predict even for
those most skilled in plant genetics.
Thus, under commonly used genetic practices, we are adding
hundreds of thousands of unknown genes into our common com-
mercial crop plants through traditional agricultural practices. In
comparison, the new genetic engineering technology will add a few
characterized genes to a plant. The properties of the progeny from
a genetic engineering experiment will be far easier to predict than
24
those produced through a cross between corn and teosinte. That is
design. That is engineering. That is genetic engineering.
Senator Durenberger. When are you bringing on the cow?
Dr. Brill. Breeders are not concerned that any plant resulting
from such a cross between corn and teosinte will spread in an un-
controlled manner; in other words, become a problem weed. This is
in spite of the fact that new, entirely uncharacterized genes are
being introduced into the corn plants. The lack of concern is based
on the many centuries of experience mankind has had as a plant
breeder.
Corn seed, if thrown into your yard or into the woods, will not
take over like dandelions or crab grass would. Scientists now un-
derstand that at least hundreds, and perhaps thousands, of very
specific genes are necessary to convert corn into a problem weed. It
is not reasonable to expect that in the foreseeable future any labo-
ratory could hope to purposely engineer corn to become a problem
weed. To do so by accident is essentially impossible.
Thus, in the genetic engineering of plants, where one or several
well-characterized genes are intentionally put into specific domesti-
cated plants, the possibility of any plant coming out of this process
which could in any way be a competitive weed is even more unlike-
ly.
The prospect of genetic engineering of plants offers the possibili-
ty of reducing some of the adverse genetic consequences of present
agricultural practices. Current practices with chemical herbicides
and insecticides frequently cause genetic changes in weeds and in-
sects. In other words, we are now causing gene changes in danger-
ous organisms.
It is paradoxical that it is the very goal of many of the genetic
engineers to make our future agricultural practices less dependent
on such chemicals with their adverse consequences. Let me stress
this: Most applied genetic engineering work currently going on is
aimed to replace some of our most noxious chemicals. As an envi-
ronmentalist, I am happy to be involved in this activity.
It has been said that because we struggle now with several prob-
lem organisms, such as kudzu vine, Japanese beetle, or gypsy moth,
that we need to have concerns about genetically engineered plants.
This assertion is faulty in its premise. These problem organisms
are not the result of relatively minor genetic changes, such as
those the genetic engineer would make. When kudzu, Japanese
beetle and gypsy moths came to the United States, they thrived be-
cause their natural competitors were lacking and, therefore, the in-
troduced organism took over in their new environment. That is
why kudzu vine, Japanese beetle, and the gypsy moth have caused
problems.
It is the purpose of our laws governing importation of organisms
from other countries to help us control these kinds of problems.
f There is nothing about these experiences that would suggest that
i any plant, with changes, additions or deletions of one or a few
1 characterized genes could create this kind of problem.
^ The point I am making here is equally applicable to microorga-
nisms, such as bacteria and fungi, for agricultural use, as it is to
plants. So let me talk briefly about microorganisms.
25
Here is a container filled with bacteria that was once sold to im-
prove the growth of clover. On the label on the box it says that it
contains 15 billion germs, for 1 bushel. This was produced in 1920. I
am showing it to you to illustrate that bacteria and fungi have
been freely grown in huge quantities for many decades and that
field experiments have been conducted around the world using
these organisms. Such introduced organisms in the soil continually
mutate and exchange genes, resulting in a great genetic variability
of the organisms we added.
Each year new microbial products for agricultural use are intro-
duced. Yet in spite of all of this widespread use, there has never
been a single confirmed report that I know of in which a microbial
culture, considered safe, has caused a significant problem in any
field, even in its experimental field testing stages.
As a society we constantly add cultures of microorganisms to our
environment. Cultures of billions of uncharacterized microbes are
added to the environment every time a piece of rotted fruit or
other food is thrown into the woods. Environmentalists are not con-
cerned that the ecology of those woods will be disrupted. There are
reasons why there has been no such problem. Nature is resilient,
and the original balance of microbes tends to return to an environ-
ment over time. There is no reason to believe that a microbe which
does not now cause problems to the environment will persist in the
environment or begin to cause problems when it has a few well-
characterized foreign genes added to it.
You may ask what is the chance that we could accidentally
produce a disease-forming microbe by genetically engineering, for
agricultural use, a known harmless microbe? Scientists have now
shown us that many genes are necessary for an organism to
become a problem pathogen. Thus, the chance of accidentally creat-
ing a microbial pathogen by introducing a few identified genes in a
nonpathogenic microorganism is virtually nil.
It would perhaps be more settling to the public at large if labora-
tory or greenhouse tests could demonstrate that a particular ge-
netically engineered plant or microbe would be safe in the general
environment. However, there is no way known to mimic the com-
plex interactions between plants, microbes, soils, soil treatments,
and the weather. In order to test the effect of any agricultural
product, field tests are essential.
In summary, from practical and scientific experience, I assert
that it would be extremely difficult to purposely engineer a plant,
bacterium or fungus now considered harmless to become a signifi-
cant problem to the environment or to public health. To make a
harmless organism become a problem accidentally v/hile creating
an organism useful to agriculture is virtually impossible.
The very improbable risk scenarios described by the opponents of
this technology obviously need to be weighed in balance with the
benefit to be obtained from it. As Thomas Jefferson once said, "The
greatest service which can be rendered any country is to add a
useful plant to its culture."
My message today is that I do not see any likelihood of any po-
tential serious negative environmental consequences of genetic en-
gineering of agricultural plants or microorganisms in the foreseea-
ble future. Therefore, I do not believe there is any need to rush
26
into any overhaul of the existing review and regulatory procedures,
which we believe are adequate, since the possibility of harm is so
small and the probability of benefit is so great.
Of course, we are hurting personally, but I mention this because
we are contending for the lead in the United States and, hopefully,
the United States will be the world leader in agricultural applica-
tions of genetic engineering. Agracetus has lost two growing sea-
sons, 2 years, because approval from NIH has still not been grant-
ed, even though the Recombinant DNA Advisory Committee has
twice approved, on the basis of an extensive review of safety consid-
erations, Agracetus' request to perform a very small and contained
field test.
Thank you.
Senator Durenberger. Thank you very much.
On that latter point, would you explain why you can't just go
ahead with the field test?
Dr. Brill. We are waiting for Dr. Wyngaarden's OK which we
have not received.
Senator Durenberger. Why do you have to wait for them?
Dr. Brill. Because we want to comply' with the NIH RAC guide-
lines.
Senator Durenberger. Why do you want to comply with them?
Dr. Brill. It is important for us. No. 1, to be perceived as being a
responsible company. It is important for me personally to actually
be responsible. And it is a new technology, and I think a new tech-
nology ought to have at least some kind of review.
Senator Durenberger. Other than for those reasons, do you
think you have to wait? What seems to be holding it up?
Dr. Brill. We don't have to wait. We would rather go by what-
ever regulations the U.S. Government comes up with, if any.
Senator Durenberger. Let's talk about that. Dr. Alexander.
Would you describe for us the kinds of tests that you think would
be needed in a regulatory program for release of novel organisms?
Dr. Alexander. I think it is not too difficult to do most of the
types of tests that are required. They are not difficult. They will
not be expensive. The items in the areas of ignorance I indicated
would reflect the sorts of tests. Will the organisms survive? It is
simple to measure. Will the organism multiply? That, too, is simple
to measure. Will it transfer genetic information? That could be a
real problem to test. Is it transported from place to place? That,
too, one can measure.
The difficult area where I think there needs to be research is in
the area of measuring effects. That we do not know how to do in a
convenient, testable system.
Differing from what Winston Brill said, I do believe there are
systems that EPA has developed for testing reasonable environ-
mental models so that we can measure interactions among species
in a contained area.
These tests are simple, straightforward, not time consuming and
not overly expensive, except for the last procedure, measuring ef-
fects. I would expect that most organisms that are being considered
for genetic engineering will fail one of those four tests, so that they
will be approved.
27
If an organism passes all four and has to be tested for its impact
on plants and animals, it will take time and it will be expensive.
But I think it is a degree of caution we ought to have in order to
protect ourselves.
Senator Durenberger. Dr. Brill, do you want to react to that?
Dr. Brill. Yes. If there are tests that are relevant, I would cer-
tainly very much support them. I am a bacteriologist. The first test
I guess was just to look at populations in the field. Depending on
the organism, and I would predict it would be for most organisms
that would be used in the future, that can be extremely difficult
and would involve, in fact, more genetic engineering to get mark-
ers so you can pick out the one organism of the millions that are in
a handful of soil
For some organisms there are simple ways to examine popula-
tions in the field. For most microbes, I think most that will be ap-
plied to agriculture, there are no ways of doing it. It may not even
be relevant to determine population levels. In other words, in some
situations one organism per handful could be a problem, and in
other cases a billion organisms per handful might be needed to
cause a problem.
In some disease cases, a couple of organisms can cause illness. In
other cases many, many, many are needed to cause disease. So, I
question the relevance of the data. I mean one can do experiments,
but thought is required to determine the relevance of the results to
safety questions.
This is probably the best understood microorganism that is used
in agriculture today. It is called Rhizobium. Today, with the labora-
tory work of Martin Alexander and myself, Winston Brill, and hun-
dreds of other laboratories over many, many decades, I can't tell
you very easily if I threw this in the soil how long it will persist, or
how well it would increase in number in the field. It is extremely
difficult.
Now, this organism is among the best understood of bacteria.
Other organisms are not so well understood.
Senator Durenberger. Dr. Alexander, in your statement you
said that many of the microorganisms that have devastated our
crops are genetically similar to the species that previously had
little effect. Are you saying that even minor changes in the genetic
make-up of an organism can lead to what you might call major dif-
ferences in effects on plants and animals?
Dr. Alexander. I can cite worst case examples where the answer
is yes. There are a number of instances where a simple genetic
change alters an organism from a harmful species to a nonharmful
species, and presumably the other can be done as well, and in some
cases it has been shown. In fact, one of the pioneering experiments
in the field of molecular genetics did essentially that.
My concern isn't that I think it is simple to make these changes.
The concern is that I am not sure. There are examples of potential
problems with these genetic changes. There are many, many exam-
ples of nonproblems. This is why, given the expanding scope of the
technology, I think we do have to have the information. We do
have to have the tests for specific species.
28
Senator Durenberger. Are you saying that a gene that is deUb-
erately placed in one organism can be transferred to a different
kind of organism?
Dr. Alexander. The gene can be transferred to different orga-
nisms, that is correct, or the genetic make-up of a single organism
can be modified so it will affect a plant or an animal. We have
good examples in human pathology — pneumonia, for example. Or
we can potentially change an organism so it acts on different spe-
cies. That is the issue underlying the need for regulation of micro-
organisms to be used as pesticides.
Senator Durenberger. Obviously, in the agriculture field we are
worried about placing a gene in a controllable organism, like a
corn plant, which might get transferred to a weed, for example.
What kinds of environmental consequences occur from that kind of
a transfer?
Dr. Alexander. I am a bit more familiar with the microorganism
side of things. But if a deleterious gene is transferred and is ex-
pressed, then the potential for a problem does exist.
We have very few examples of which I am aware in the field of
plant sciences. However, the potential is there. As we move away
from simple recombinant DNA technology to a variety of genetical-
ly more complex manipulations, the probability of this event goes
from, let us say, vanishingly small to reasonably small.
Senator Durenberger. Why don't you take a crack at that ques-
tion with regard to microorganisms.
Dr. Alexander. We know that many organisms that do no harm
are very similar to organisms that cause considerable injury, as in
the current concern with citrus canker. Members of the same
group of organisms are widespread in nature but do no harm at all,
or act on entirely different plants.
If the genetic information, and in some cases that is a small
amount of genetic information, is then transferred to a harmless
organism, that new organism could, in fact, do injury.
I think the probability is very small because that should have oc-
curred in nature. But we can do much more genetically in the iso-
lated laboratory than in nature and in a short period of time.
Senator Durenberger. Dr. Brill, do you want to respond to that?
Dr. Brill. I guess I disagree with that last statement. I think
nature is much more versatile than any of the genetic engineers
that are presently working and those that will be working. People
have appreciated the dynamics of gene exchange in nature. There
are naturally systems where bacterial genes, without man's inter-
vention, have gotten into plants. If two organisms are somewhat re-
lated, you can bet they will exchange genes, in every single com-
bination. So there is tremendous versatility.
The one thing I would like to comment on is Dr. Alexander's
statement that problems have been caused by certain gene changes
in nature. That is true. I mentioned a couple. I mentioned insect
resistance to insecticides and weed resistance to herbicides. You
can take microbes that are resistant to antibiotics.
Those became problems not because of gene change. Those
became problems because of man's addition of chemicals. All of
these problems can be remedied merely by removing the chemicals.
29
He is absolutely right, it is a one-gene change. But it is not that
all of a sudden something came up and we are straddled with a
problem. What came up was the chemical selection which forced
that gene to change. That is very, very different than what we are
talking about regarding genetic engineering.
Senator Durenberger. On Thursday, Dr. Daniel Simberloff, who
is an expert on invasion by exotic organisms, may differ with that
statement. I think he is going to indicate, and he uses the apple
maggot, the planthopper, and maybe some others as examples, that
there is a spontaneous change involved in these kinds of invasions
or outbreaks or whatever. Would you disagree with that?
Dr. Brill. No; I agree with that. In fact. Dr. Alexander said prob-
lems frequently occur when you change the ecology, change the en-
vironment somewhat. One way to change the environment is to
bring in a new plant. Sometimes when you bring in that new plant
you may also bring in an insect that doesn't like living, let's say, in
the United States that much, but eventually there will be a muta-
tion where the insect does well in its new environment and causes
problems.
Senator Durenberger. Dr. MacLachlan, let me ask you: Suppose
we have a frustrated bacteriologist who is associated with an effort
that might make the United States of America the world leader in
a certain area but can't get approval to test his product through a
Federal organization that doesn't want some of this regulatory re-
sponsibility. Obviously, if duPont is known for anything, it is
known for innovation and it is known for leadership in a wide vari-
ety of areas and for making this country a leader in a lot of these
areas.
Where are we left here in the near term in balancing regulation
against experimentation and innovation? How far do we have to go
in the direction that Dr. Alexander recommends we go, that we go
to the testing of genetically engineered organisms so that we don't
get in the way, if you will, of some process of new product develop-
ment and innovation?
Dr. MacLachlan. I guess I look at it like this. We are in the
early stages of a learning curve. As you said. Senator, in your in-
troduction, this is an embryonic science and there is a lot to be
learned as we progress with its implementation into commercial
products. In my opinion, this is natural. There are a lot of things
we now are worried over and not sure about. However, as we
progress together on the learning curve we will be able to convince
the public we are responsible and are proceeding with due regard
for safety.
How do we do this? I guess I look at it as a partnership made up
of industry, the appropriate Government agencies, and scientific
experts. The existing agencies like the FDA and so forth have had
long experience in effectively dealing with conventional materials,
but now they are faced with dealing with these bioltechnology pro-
duced materials. While in many cases, this is not really dealing
with anything fundamentally different, especially as far as the de-
sired effects go, there are many new considerations to manage.
It seems to me, even though I am not a bacteriologist or biologist,
the risks are extremely low and I think Dr. Alexander has said
that. It also seems to me that we must, for the time being, evaluate
39-383 O— 84-
30
each situation on a case-by-case basis. As I just said, industry work-
ing with the appropriate Federal agency and in turn working with
scientists skilled in the new technology is the way to do it. Right
now the best skill group already in place is the RAC, and they
should continue to be used.
I would hope we can start right now with this partnership and
maintain it through the infancy of this new industry. I don't know
any other way to do it. We need to listen to the concerns and ad-
dress them. Sometimes this may force us to slow down or cost sub-
stantial sums of money. In most cases I think we can expeditiously
resolve the concerns at least to a point of minimum risk. We will,
of course, ultimately have to take some risks. However, for the
most part, the kinds of questions we will be dealing with in the
near future will not be that complex or costly to satisfy relative to
our concerns.
As we progress with this new technology, we will be dealing with
ever more complex questions, but we will also have more knowl-
edge and experience. For example, moving several genes around si-
multaneously. Where today that might present some very hard
questions to answer, in the future we will feel comfortable with
such advanced technology. So let's go forward with a partnership.
Senator Durenberger. Dr. Alexander, following on that same
line, I wonder what your views might be about regulation in this
area in the general sense. Clearly if we enlarge the scope of the
environmental problem and I don't know anything about Dr. Brill's
specific request that he has before NIH, but if we enlarge the scope
of the perceived problem, then it seems to me we delay the time at
which we can address certain kinds of products, if you will, that
don't present quite that large a problem, maybe a lesser problem.
I don't know whether Dr. Brill is caught in that kind of situation
or not. But I think we all understand that regulation in this area
of the environment is undergoing some change and that if we rely
on existing bureaucracies, whether it is NIH or EPA or the FIFRA
people at USDA or whatever, they are more likely, under societal
pressure, to do nothing or to overreact or, as they say, protect the
opinions and the reputations of the bureaucracy. In other words, to
slow down the process of decisionmaking rather than to speed it up
or encourage it.
I am curious to know whether or not after you have told us here
in a very practical sense some of the knowledge base we need to fill
whether you have some suggestions about the process for filling
them. Dr. MacLachlan gave us some specific recommendations on
the regulatory approach. Do you have some specific recommenda-
tions to make to us as you look at the role that TSCA plays and
some of these other Federal laws?
Dr. Alexander. If we have a high-risk technology, as we have in
the case of pesticides or drugs, then obviously one must have an
expensive and very careful evaluation. I think we all agree that
this is a low-risk technology, but I don't agree it is a no-risk tech-
nology.
If that is the case, I think we do have precedents in the Federal
system for regulations of new materials that are being introduced.
TSCA has that concern under Section 5, the PMN procedure. That
approach requires no information for the PMN. The information
31
has to be provided if it is available, but it requires developing no
new information.
This approach, I think, would have to be modified because in the
field of behavior of novel organisms, in contrast with the behavior
of novel chemicals, we don't yet have a science. I think that some
modest information ought to be required.
As you know far, far better than I do, speeding up the bureaucra-
cy is not easy to do. The process will be slow. The testing will
impose a cost. It will delay industry. But if the precedent of TSCA
and the PMN system were a bit more concerned with novelty and
with biology than presently exists, and if this is coupled with some
science, we would have a reasonable degree of certainty, a mini-
mum of delay prior to the development of products and a maxi-
mum of benefit for agriculture and in pollution control.
So I do not believe that we are really proposing anything that
enormous in terms of a regulatory system. I believe it can be done.
But the two things that are really required are a sensible regulato-
ry framework and information which does not not exist in this
area.
Senator Durenberger. Dr. Brill, now that you have had consid-
erable experience with our current approach and you have heard
from EPA here earlier today about some of the areas in which they
propose, through the rulemaking process, to get involved in, what
are your recommendations as to how we might structure this regu-
latory response?
Dr. Brill. I guess my first recommendation is that somehow the
danger/ safety issues that have been mentioned here ought to be
discussed at a scientific level.
After that, or after the results of such discussions have been re-
viewed, if the public still has a concern, there ought to be some
type of regulation and, hopefully, that regulation will be based on
scientific experience and the public's knowledgeable perception of
the safety issues.
Senator Durenberger. Dr. Alexander, you heard me refer in my
opening statement to lignin, because it is my understanding that
scientists are experimenting on the effect of the decomposition of
lignin and perhaps how it affects other fundamental functions of
the ecosystem. Do these kinds of experiments trouble you? In other
words, are there some kinds of genetic manipulations that in your
opinion are more environmentally dangerous than others that we
can predict?
Dr. Alexander. There are a number of visible munipulations.
The lignin case is a good point. Steps in the process we know as
nitrification represent another case. In each instance, let's say I am
quite concerned about this. I would like to have meaningful envi-
ronmental information, and I would like to have good tests, and
not simply than a group of people who merely vote for what is good
or is bad without having data from tests and from research.
I probably am wrong in my concern with these processes, and
other people can come up with better scenarios for ecological per-
turbations resulting from some type of genetic manipulation. It is
when these legitimate concerns are laid to rest, using data from re-
search or testing, that I think we would feel much more comforta-
ble. As we know, even in the area of drugs, there will be products
32
that slip by our research and testing guidance. ThaUdomide is a
good example of this. But the frequency of problems is markedly
reduced once there is good scientific information once there is good
regulation.
Senator Durenberger. Do either of the others want to comment
on the question of whether or not there are certain genetic manip-
ulations that are clearly more environmentally dangerous than
others? Dr. Brill?
Dr. Brill. I would like to comment, since you introduced the ses-
sion with the lignin problem, that a lot is known about lignin deg-
radation. Organisms that are best at degrading lignin do so very,
very slowly. People are studying how lignin is degraded. Lignin is
an extraordinarily complex molecule. Many, many enzymes are re-
quired in order to degrade lignin. Once again, the chance of doing
so accidentally is nil. I mean if one wants to do so purposely, it
would take at this point I think a number of years of research fo-
cused on lignin degradation to get an organism unable to degrade
lignin to be able to do so efficiently. That is, to get it to degrade
lignin at rates equivalent to those in organisms already in our en-
vironment.
Another point I would like to make, which I think is important,
is your frequent comparison between regulation of chemical prod-
ucts and biological products. If a chemical is known to be safe, a
minor change in its structure may make it exceedingly dangerous.
Because of this, the new chemical has to be tested independently of
the knowledge that the first chemical is safe. That is not true for
microorganisms. Microorganisms or plants or animals have consist-
ently been very variable, with the differences in cattle, differences
in plants, the differences in microbes. So we have gotten to live
with variability and feel safe with it. I think you have to be careful
when you compare chemicals with organisms.
Senator Durenberger. Thank you all very much. We certainly
do appreciate the time and effort that you have put into your testi-
mony todpy.
The hearing will be adjourned. We will reconvene on Thursday
morning with the second half of our hearing.
[Whereupon, at 12:05 p.m., the subcommittee was recessed to re-
convene at 10 a.m. Thursday, September 27, 1984.]
[Statements submitted for the record follow:]
33
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
National Institutes of Health
Bethesda, Maryland 20205
STATEMENT
RY
BERNARD TALBOT, M.D., PH.D.
ACTING DIRECTOR
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
NATIONAL INSTITUTES OF HEALTH
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE THE
COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
SUBCOMMITTEE ON TOXIC SUBSTANCES AND ENVIRONMENTAL OVERSIGHT
UNITED STATES SENATE
SEPTEMBER 2";, 1^84
34
I am Dr. Bernard Talbot, Acting Director of the National Institute of
Allergy and Infectious Diseases, at the National Institutes of Health.
I have been associated, since 1975, with the original preparation, and
with all subsequent revisions, of the NIH Guidelines for Research
Involving Recombinant DNA Molecules. These safety standards were
developed in response to a request by scientists that the National
Institutes of Health devise "guidelines to be followed by investigators
working with potentially hazardous recombinant DNA molecules."
Overseeing the NIH Guidelines is the NIH Recombinant DNA Advisory
Committee (called RAC for short). The RAC consists of 25 voting members
appointed by the Secretary of Health and Human Services, plus non-voting
representatives of Federal agencies who participate actively in the RAC
meetings. The voting members include eminent scientists of many different
disciplines, a lawyer, a former State legislator, an occupational safety
expert, a housewife, practicing physicians, and a bioethicist. Federal
agencies with representatives on the RAC are the: National Science
Foundation; Department of Agriculture; Environmental Protection Agency;
Food and Drug Administration; Department of State; Veterans
Administration; Department of Energy; Centers for Disease Control;
National Institute for Occupational Safety and Health; Department of
Commerce; Department of Interior; Department of Transportation;
National Aeronautics and Space Administration; Department of Labor;
Department of Defense; and Office of Science and Technology Policy.
35
Any proposed revision of the NIH Guidelines must first be published for
public comment, and then discussed and voted on by the RAC in open
session, before it may be adopted by NIH.
3
The NIH Guidelines were first issued in July 1976. Those 1976
Guidelines included classes of experiments that were "not to be
performed." This included "deliberate release into the environment of
any organism containing a recombinant DNA molecule."
4
The first revision of the NIH Guidelines, issued in December 1978
reorganized the classes of experiments previously listed as "not to be
performed" into a section entitled "Prohibitions" including "deliberate
release into the environment of any organism containing recombinant
DNA." However, the Guidelines noted that "Experiments in these
categories may be excepted from the prohibitions . . . provided that
these experiments are expressly approved by the Director, NIH, with
advice of the Recombinant DNA Advisory Committee after appropriate notice
and opportunity for public comment."
5
The revision of the Guidelines issued in April 1982 changed the section
entitled "Prohibitions" to one entitled "Experiments that Require RAC
Review and NIH and Institutional Biosafety Committee Approval Before
Initiation." Included again under this category was "deliberate release
into the environment of any organism containing recombinant DNA."
The most recent complete revision of the Guidelines, issued in June
1983 specifies new procedures to facilitate the approval of field
36
testing under certain specified conditions of certain plants modified by
recombinant DNA techniques; these now require review by the RAC Plant
Working Group, but no longer by the full RAC, prior to approval by NIH.
In addition to review by the full RAC, or the RAC Plant Working Group,
prior to approval by the NIH, any deliberate release to the environment
also requires prior approval by the local institutional biosafety
committee.
To date three cases of deliberate release to the environment have been
approved by NIH. In each such case:
(1) Notice was placed in the Federal Register at least 30 days prior to
the RAC meeting at which the proposal was discussed, giving notice
and inviting public comment on the proposal.
' (2) The proposal was discussed at an open session of a RAC meeting,
with active participation in the discussion by the Department of
Agriculture representative. During the discussion the RAC
carefully considered the possible hazards of the experiment. This
involved some RAC members proposing "scenarios" of possible hazard,
and other RAC members replying as to why the "scenarios" were
extremely unlikely to occur. Following the discussion, the RAC
voted in each of the three cases to recommend approval of the
proposal .
37
(3) Advice was sought from the Department of Agriculture Recombinant
DNA Advisory Committee which in each of the three cases recommended
approval of the proposal.
(4) NIH approved each of the proposals with a notice in the Federal
Register explaining the request, and the reasons for granting
approval .
The three cases are: approval to Dr. Ronald Davis of Stanford
University to field test corn plants transformed by corn DNA; approval
g
to Dr. John Sanford of Cornell University to field test tomato and
tobacco plants transformed with bacterial and yeast DNA; and approval to
Drs. Steven Lindow and Nickolas Panopoulos of the University of
Q
California, Berkeley to release Pseudomonas syringae and Erwinia
herbicola carrying deletions in the genes involved in ice nucleation,
for purposes of biological control of frost damage in plants. None of
these field tests has actually been conducted to date.
NIH is not a regulatory agency and has no statutory authority over
industry. NIH's mission is the funding of research, and it has
authority to impose requirements only on those institutions which accept
NIH research funds, with the maximal possible penalty for non-compliance
being the cutoff of such NIH funds. Most of industry does not receive
NIH funds for recombinant DNA research, and, therefore, is not required
to comply with the NIH Guidelines.
38
During the 95th Congress (1977-1978) sixteen different bills dealing with
recombinant DNA were introduced. The most extensive set of hearings
were held by the House Subcommittee on Science, Research and Technology,
chaired at that time by Congressman Ray Thornton. (After leaving
Congress, Mr. Thornton subsequently was a member (1979-1982) and Chairman
(1980-1982) of the NIH Recombinant DNA Advisory Committee), In the
Senate hearings were held both by the Subcommittee on Health and
Scientific Research, of the Committee on Human Resources, and by the
Subcommittee on Science, Technology and Space, of the Committee on
Commerce, Science and Transportation. Bills which would have made the
NIH Guidelines mandatory for the entire country passed Committees in both
the House and Senate but never reached the floor of the House or Senate
for a vote. There is therefore today no national law making the NIH
Guidelines mandatory for private industry.
In the absence of national legislation. New York State and a number of
' localities'^ have passed local legislation making the NIH Guidelines
mandatory. For the rest of the country other than these localities, for
work not supported by Federal funds, compliance with the NIH Guidelines
is not mandatory. There is, however, a section of the NIH Guidelines
entitled "Voluntary Compliance" which encourages commercial organizations
to comply voluntarily with the Guidelines. At the last RAC meeting on
June 1, 1984, two proposals for field tests of genetically engineered
organisms voluntarily submitted by private companies were reviewed and
recommended for approval; a final NIH decision on these proposals has not
yet been made.
39
12
In September 1983, a law suit was filed by Jeremy Rifkin and others charging
violation of the National Environmental Policy Act, and in May 1984 Judge
John Sirica issued a preliminary injunction enjoining the NIH from
approving "deliberate release" experiments submitted by NIH grantee
institutions, although specifically allowing NIH to approve such
experiments voluntarily submitted by industry. The government is
appealing the preliminary injunction.
In April 1984 the Cabinet Council on Natural Resources and Environment
13
Working Group on Biotechnology was established. It consists of
"representatives of the Departments of the Interior, State, Justice,
Agriculture, Commerce, Energy, Health and Human Services and Labor, the
Environmental Protection Agency, the Council on Environmental Quality,
the Council of Economic Advisers, the Office of Management and Budget,
the Office of Policy Development, the Office of Science and Technology
Policy, and the National Science Foundation." It is directed "to
undertake a review of the federal regulatory rules and procedures
relating to biotechnology" including reviewing the function of the NIH
Recombinant DNA Advisory Committee "and its role in biotechnology
commercialization and safety regulation."
This concludes my prepared testimony. I will be pleased to answer any
questions.
40
FOOTNOTES
1. "Potential Biohazards of Recombinant DNA Molecules" appeared
simultaneously in Science 185 , 303, 1974; Nature 250 . 175, 1974, and
the Proceedings of the National Academy of Sciences 71, 2593, 1974,
by Drs. Paul Berg, David Baltimore, Herbert Boyer, Stanley Cohen,
Ronald Davis, David Hogness, Daniel Nathans, Richard Roblin, James
Watson, Sherman Weissman and Norton Zinder.
2. The representatives of Federal agencies to the NIH Recombinant DNA
Advisory Committee are: Dr. Herman Lewis, National Science
Foundation; Dr. Sue Tolin, Department of Agriculture; Dr. Morris
Levin, Environmental Protection Agency; Dr. Henry Miller, Food and
Drug Administration; Dr. William Walsh, Department of State; Dr.
Richard Green, Veterans Administration; Dr. George Duda , Department
of Energy; Dr. Walter Dowdle, Centers for Disease Control; Dr.
Richard Lemen, National Institute for Occupational Safety and
Health; Mr. John Cox, Department of Commerce; Dr. Mariano Pimentel ,
Department of the Interior; Dr. George Cushmac, Department of
Transportation; Dr. Donald DeVincenzi, National Aeronautics and
Space Administration; Dr. Ralph Yodaiken, Department of Labor; Dr.
William Beisel, Department of Defense; and Dr. Bernadine Bulkley,
Office of Science and Technology Policy.
3. NIH Guidelines for Research Involving Recombinant DNA Molecules.
Federal Register , July 7, 1976, Part II, pages 27902-27943.
4. NIH Guidelines for Research Involving Recombinant DNA Molecules.
Federal Register , December 22, 1978, Parts VI and VII, pages
60080-60131.
5. NIH Guidelines for Research Involving Recombinant DNA Molecules.
Federal Register , April 21, 1982, Parts II and III, pages
17166-16198.
6. NIH Guidelines for Research Involving Recombinant DNA Molecules.
Federal Register , June 1, 1983, Parts II and III, pages 24548-24581.
7. Approval appeared in the Federal Register , August 7, 1981, page
40331.
8. Approval appeared in the Federal Register , April 15, 1983, page
16459.
9. Approval appeared in the Federal Register , June 1, 1983, page 24549.
10. Hearings before the Subcommittee on Science, Research and
Technology, Committee on Science and Technology, U.S. House of
Representatives, on "Science Policy Implications of DNA Recombinant
Molecule Research." Hearings held on March 29, 30, 31; April 27,
28; May 3, 4, 5, 25, 26; and September 7 and 8, 1977.
11. Localities requiring compliance with the NIH Guidelines are:
Amherst, Massachusetts; Berkeley, California; Boston, Massachusetts;
41
Cambridge, Massachusetts; Emeryville, California; Newton,
Massachusetts; Princeton, New Jersey; Somerville, Massachusetts; and
Waltham, Massachusetts.
12. Foundation on Economic Trends, et al., v. Margaret M. Heckler, et
al., Civil Action No. 83-2714 in the United States District Court
for the District of Columbia.
13. Memorandum of April 30, 1984 from Martin L. Smith, Deputy Assistant
Director for Energy and Natural Resources, Office of Policy
Development, the White House, to the Secretary of the Interior; the
Secretary of State; the Attorney General; the Secretary of
Agriculture; the Secretary of Commerce; the Secretary of Energy; the
Secretary of Health and Human Services; the Secretary of Labor; the
Administrator, Environmental Protection Agency; the Chairman,
Council of Environmental Quality; the Chairman, Council of Economic
Advisers; the Director, Office of Management and Budget; the
Director, Office of Science and Technology Policy; the Director,
Office of Policy Development; and the Director, National Science
Foundation.
42
STATEMENT OF
DR. JOHN A. MOORE
ASSISTANT ADMINISTRATOR
FOR PESTICIDES
AND TOXIC SUBSTANCES
U.S. ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE
COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
SUBCOMMITTEE ON TOXIC SUBSTANCES AND ENVIRONMENTAL OVERSIGHT
UNITED STATES SENATE
SEPTEMBER 25, 1984
Mr. Chairman and members of the Subcommittee, I am Dr.
John A. Moore, Assistant Administrator for EPA's office of
Pesticides and and Toxic Substances. I am pleased to have
this opportunity to discuss with the Subcommittee this morning
the future directions the Environmental Protection Agency (EPA)
is considering in the regulation of genetically-engineered
organisms. Two offices within EPA, the Office of Pesticides
and Toxic Substances (OPTS) and the Office of Research and
Development (ORD) , have been looking at the issue of intentional
release of genetically-engineered organisms, and have been
developing regulatory programs to address this important
issue.
Before discussing the specific actions EPA intends to
take in this area, I would like to share with you my per-
spectives on the growing biotechnology industry. Biotechnology
is the application of biological science towards technological
ends such as the production or use of chemicals or life
forms for commercial or potentially commercial uses.
Recent developments in biological sciences have greatly
enhanced scientists' ability to manipulate genetic material
43
and to develop new microorganisms, plants and animals. These
advances are expected to lead to the availability of a
variety of useful products in a wide range of industries,
including chemical production, agriculture and environmental
protection. Commercial products of biotechnology are
expected to be available in the very near future. The many
possible applications of biotechnology may fulfill many of
society's needs by alleviating problems of disease and pollu-
tion, and increasing the supply of food, energy and raw
materials. As with any new process, there are questions
about the human health and environmental implications of
developing and using microorganisms for commercial purposes,
particularly when their use involves a release into the environ-
ment. Novel microorganisms, whether they are non-indigenous
or whether they are actually genetically manipulated organisms,
may be placed in ecosystems where they have not existed
before and where natural mechanisms for controlling their
populations may not exist.
To address these concerns, EPA is developing a regulatory
framework for reviewing certain commercial products of
biotechnology that would come under our jurisdiction and review
before they are intentionally released into the environment.
We will be invoking our statutory authority to review, and
where necessary, regulate products intended for commercial
use. We are not intending to arbitrarily extend our authority
44
to all products or processes of biotechnology. Within the
next few months, EPA intends to publish two Federal Register
notices addressing EPA's statutory authority and planned
regulatory approaches in this area. It is my understanding
that other agencies that have regulatory authority in this
field are also preparing such guidelines.
The first Federal Register notice will be an interim
policy statement specifically dealing with the field testing
of novel microbial pesticides which EPA is addressing under the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
EPA defines novel microbial pesticides to be those which
contain naturally occurring microorganisms for use in environ-
ments where they are not native, or microorganisms which
have been genetically altered or manipulated by humans.
This interim policy will require a notification to EPA prior
to all small-scale field tests involving deliberate release
into the environment. This notification requirement will
permit EPA to determine whether an experimental use permit
will be required before small-scale field testing is conducted.
This interim procedure will not apply to studies conducted
in contained experimental facilities such as laboratories,
growth chambers, green houses or other facilities where
there is no deliberate release of the microbial pesticide
into the environment. We recognize that care must be taken
45
to enable the risk assessment experiments to be conducted in
order to build a scientific basis for appropriate regulation.
EPA believes that this notification procedure, which will be
designed to be timely and efficient, will allow the Agency to
evaluate the potential risks of field tests with only a minimum
impact on the development of beneficial novel microbial pesticides
for use in the environment.
The second and more general Federal Register notice will
discuss the Agency's broad policy regarding the regulation of
novel microbial products under both the Toxic Substances Control
Act (TSCA) and the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA). This notice will clarify EPA's regulatory authority
over novel microbial pesticides and will outline the Agency's
specific plans for reviewing and registering these pesticides
under FIFRA. The notice will also discuss EPA's proposed
policy for reviewing novel microbial products under TSCA. In
particular, EPA believes that novel microbial products produced
by recombinant-DNA, cell fusion, or other techniques of genetic
engineering are "new" chemical substances subject to the Pre-
manufacture Notification (PMN) requirements, unless they are
substances such as drugs or pesticides that are excluded by
statute from TSCA regulation. The Agency also intends to
address the applicability of TSCA requirements to field
tests or other research and development activities. The
notice will provide an opportunity for public comment on how
39-383 O— 84-
46
the Agency should apply these two statutes to novel microbial
organisms. Although a large volume of comments is anticipated,
EPA will expeditiously review these comments and promulgate
the final policy quickly.
In addition to these activities, EPA's Office of Research
and Development is conducting important research in the
area of biotechnology to address three important issues: 1)
the possible public health and environmental consequences of
the release of novel microorganisms into the open environment;
2) the possible public health and environmental consequences
associated with the increase of wastes and emissions from a
growing biotechnology industry; and 3) the application of
biotechnology to improve the environment by degrading persis-
tent and toxic material to provide previously unavailable
tools for monitoring pollutants. ORD has already sponsored
workshops of scientific experts in this area from academia,
industry and government to identify the major areas where
knowledge is lacking and to define further the Agency's
research plan to address these issues. The consensus of the
experts at these workshops noted that considerable informa-
tion already exists which is relevant to the assessment of
microbials including genetically-engineered microorganisms.
However, there were recommendations that this information
needs further review and should be built upon in the future
47
to address information gaps and standard protocols that
are currently unavailable. Based on recommendations such as
these, as well as the technical and regulatory experience
from the various EPA program offices, ORD has identified a
number of areas where further applied or basic research or
other information development efforts are needed. To
ensure that the workshop recommendations and EPA plans are
appropriately developed, a biotechnology research program
management team has been formed to coordinate activities
within ORD and to facilitate responses to regulatory office
needs.
Obviously, a major issue in any regulation of genetically-
engineered organisms is the effect of federal oversight and
regulation on innovation in what is a very promising industry.
Innovation in the biotechnology field is likely to be of
major economic importance to the U.S. economy and to provide
significant benefits to the public. Unnecessary or confusing
regulations will pose a serious problem to industry and may
give a competitive advantage to foreign nations. In addition,
the biotechnology field is in its infancy and our regulatory
framework must be flexible enough to allow the evolution
of policies as new knowledge becomes available. Thus, it is
also essential that the federal government coordinate its
efforts in regulating this new industry and ensure that any
regulations imposed are necessary, consistent, and appropriate.
48
As the Subcommittee is aware, the Administration has
formed an ad hoc working group of the Cabinet Council on Natural
Resources and the Environment to address federal regulation in
this area and to ensure a consistent overall approach. EPA
is an active member of the working group and I serve as EPA's
representative. EPA also is working closely with other federal
agencies that share an interest in biotechnology including
the National Institutes of Health and the Department of
Agriculture to coordinate our multiple activities. i believe
that a coordinated federal approach in this area involving all
interested agencies will permit a highly successful biotechno-
logy industry to exist in this country, while at the same
time insuring protection of public health and the environment.
Mr. Chairman, I appreciate the opportunity to provide
the Subcommittee with this statement. I will be pleased to
answer any questions you may have.
49
STATEMENT OF
DR. E. L. KENDRICK
CHAIRMAN, USDA RECOMBINANT DNA RESEARCH COMMITTEE
FOR
SCIENCE AND EDUCATION
UNITED STATES DEPARTMENT OF AGRICULTURE
BEFORE THE
SUBCOMMITTEE ON TOXIC SUBSTANCES AND ENVIRONMENTAL OVERSIGHT
OF THE
COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
SEPTEMBER 25, 1984
50
Mr. Chairman and Members of the Subcommittee, thank you for the opportunity
to testify on the role of the U.S. Department of Agriculture on the subject
of this hearing, "The Intentional Release of Genetically Engineered
Organisms ."
The Department of Agriculture has had responsibility since its founding
over a century ago to sponsor research and encourage application of this
research for the betterment of the food, feed, and fiber needs of the
nation, in both its national and international roles. At its founding the
Department was also uniquely enjoined with the Land Grant University
development, and as a result the research and application responsibility is
fulfilled through state, federal, and private cooperative efforts. We
believe this vast network, of scientific expertise, laboratories, and
controlled environmental facilities, have indeed provided well for the
nation in the past, and with our careful planning and introduction of the
new biotechnology initiative, including genetic engineering, we will be
able to continue to so serve the nation in the future.
I recognize that this Subcommittee's immediate interest is in what is
commonly referred to as genetically engineered organisms, and most
especially wherein recombinant DNA technologies have been utilized in
plant, animal, or microbial species, and deliberate or intentional release
of the improved species is desired. However, as background I think it is
important to note that the agricultural research community has had a long
and highly successful history of developing the genetic components of
plant, animal, and microbial life for the benefit of society and its
environment broadly.
51
All the major animal and crop species used for agricultural production in
America today have been critically designed and deliberately released.
Also, millions of acres of trees are similarly designed to provide part of
our fiber needs. In total, these food, feed, and fiber production
processes, involved deliberate release into the environment of billions of
living organisms, each involving design and manipulation of their DNA
components. The corn crop alone this year has been estimated to have
2^93x10^0 plants, each with its own designed DNA components. Not only did
the total agricultural mass of living organisms interact with existing
organisms in the environment, it also withstood an array of natural and
man-made threats, while contributing vastly to society's well being. Its
complexity is staggering.
Recombinant DNA, and other closely related genetic engineering policy
issues, are addressed by the USDA Recombinant DNA Research Committee
(ARRC). Research in labcrratories and other controlled environments, as
well as release into the environment broadly is critically assessed. Each
agency in the Department that is directly concerned with recombinant DNA
research and its application and regulation is represented on the ARRC. In
addition the director of the Office of Recombinant DNA Activities of MIH,
which administers the Recombinant DNA Advisory Committee (RAC) and t'-c
guidelines, is a member of ARRC. Similarly, a National Science Foun iation
representative is also a member of the committee.
52
Other research policy committees concerned with recombinant DNA and the new
biotechnology in agriculture include the Experiment Station Committee on
Organization and Policy (ESCOP), and the Committee on Biotechnology of the
National Association of State Universities and Land Grant Colleges
(NASULGC) .
In the evaluation and review of research involving recombinant DNA,
including field experiments, the Institutional Biosafety Committees (IBC's)
are an essential feature. This is so both in federal, state, private, and
industrial facilities. The IBC's are an essential feature of the RAC and
guideline processes.
At the earliest stages of development of RAC and the guidelines for
conducting recombinant DNA research, USDA scientists and scientists from
the agricultural research community broadly were involved. Along with the
scientific community we have strongly supported the concept of a set of
standards and procedures for the conduct of recombinant DNA research in the
United States. We remain highly supportive of RAC and scientists from the
agricultural research community serve on the committee and on special
working groups constructed by the committee as needed. The ARRC was
designed to be complementary to the RAC processes and is so utilized today.
Projects and policy issues involving agricultural interests are reviewed by
ARRC on behalf of RAC and in furtherance of the guidelines processes.
53
In the Department and in the scientific community we find in place
mechanisms that provide continual review and oversight of research as new
knowledge evolves. These mechanisms also provide for special
considerations warranted by genetically engineered organisms.
We highly applaud the RAC process. With a decade of experience we find it
has earned wide respect over the nation and the world. Concepts built into
the processes early on provided for change as knowledge over time was
acquired and attracted the highest levels of expertise. A highly
participatory process with a full range of expertise and interest all have
contributed to its success. These check and balance processes have assured
that it is not self serving, but has addressed the needs of society broadly
in this area.
Research projects that envision potential release into the environment
under controlled research conditions, or ultimately broad release, have
built into them at an early stage extensive study and review of the
molecular ecology involved. Furthermore, biological containment and gene
performance in increasingly complex environments are tested under
controlled conditions. Specific environments, genetic drift, and gene
wearing in mixed systems are tested under controlled conditions. The
multitude of naturally occurring genetic accidents and the resulting
potential for interaction, as well as ecological gene training and
attenuation are similarly tested.
54
Thus the resulting plant, animal, or microbial biota to be used in
agriculture, wherein recombinant DNA technologies have been employed in
their development, are not inherently different in nature than those we
have used in the past. These resulting products should not be treated
differently.
In summary, I have outlined the evaluation and oversight activities
involving research and field experimentation with genetically engineered
organism.
Mr. Chairman, this completes my prepared statement. I will be pleased to
respond to any questions you may have.
55
STATEMENT OF
DR. ALEXANDER MacLACHLAN
DIRECTOR, CENTRAL RESEARCH & DEVELOPMENT DEPARTMENT
E. I. DU PONT DE NEMOURS AND COMPANY
BEFORE THE
TOXIC SUBSTANCES AND ENVIRONMENTAL
OVERSIGHT SUBCOMMITTEE
OF THE
COMMITTEE OF ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
SEPTEMBER 25, 1984
56
Introduction
Good morning, I am Dr. Alexander MacLachlan,
Director of the Central Research & Development Department of
Du Pont. This Department has the responsibility for doing
most of the Company's long-range basic research and for the
introduction of new technologies to the Company. I have a
Ph.D. in organic chemistry and have been with Du Pont for
27 years. As requested by the Chairman, my remarks are
directed to a discussion of Du Pont's involvement in
biotechnology and the Company's perspective as to how the
government should go about regulating this science and its
products.
Du Pont's Biotechnology Involvement
To put biotechnology into perspective, Du Pont,
this year, will have sales in life sciences, including
pharmaceuticals, radiopharmaceuticals, X-ray products,
diagnostics and agrichemicals , at a level of about $2 billion.
However, we have not, as yet, sold any genetically engineered
products.
At the outset, let me define what I mean by
"biotechnology". As I use this term this morning, "biotech-
nology" describes the directed molecular manipulation of
genetic material, often referred to as genetic engineering.
I wish to contrast this test tube splicing of DNA and its
introduction into cells to make useful products with more
traditional plant and animal breeding approaches. We see
57
biotechnology as helping us to produce new products that can
compete with those made using traditional technologies.
The United States has taken the lead in the broad
area of biotechnology at the present time. We believe that
biotechnology's most immediate and dramatic impacts will be
in human health care and in agriculture. In the area of
human health care, the ultimate objective is a disease-free
society. Biotechnology will help us to develop new diagnostic
approaches as well as to produce new and more pure vaccines
and hormone-derived drugs. In the area of agriculture,
genetic manipulation and cell culture technology will lead
to improved crop varieties that are resistant to diseases,
pests and environmental stresses. Most important, plants
that produce more food and even new crops will be developed
through biotechnology.
Over the past five years, Du Pont has committed
$150 million of capital investments in biotechnology research
facilities. We made this decision for several reasons. First,
we expected the new biotechnology to make a significant impact
in our current and future life science based business--diagnostics ,
pharmaceuticals, agrichemicals, as well as in our commodity
chemical businesses. Second, we recognized that the tech-
niques of biotechnology were essential for research in any
life science area and that the understanding from use of the
58
techniques indirectly would lead to major new products and
processes. Third, we expected to engineer cells that would
produce products and also, in the longer term, would them-
selves be products.
In short, Du Pont has a major stake in the life
sciences research effort. We have invested substantial
human and financial resources in this business sector.
Government Regulation of Biotechnology
With this background on Du Font's efforts in the
field of biotechnology, let me now turn to Du Font's view of
how the government should regulate this emerging business field,
We believe that regulations governing the introduction of
bioengineered organisms into the environment and the manufac-
ture and distribution of products utilizing recombinant DNA
technology are inevitable and will be implemented. It is
necessary to distinguish, however, between the control of
science and the regulation of industrial products and tech-
nology. Regulatory approaches should protect the p\iblic
interest but should not place undue burden on this emerging
industry. We do not believe that the external control of
basic laboratory science in biotechnology is advisable or
necessary beyond the precedent established by "RAC", the NIH
Recombinant DNA Advisory Committee.
Insofar as I am aware, academic, government and
industrial laboratories have operated, since 1976, under the
safety and reporting aspects of the NIH RAC guidelines. The
prevailing conviction of the scientific community, and the
59
view that Du Pont supports, is that the NIH guidelines,
together with RAC ' s case-by-case review of laboratory experi-
ments, are a thoroughly sound basis for ensuring public and
environmental safety.
While the NIH guidelines are adequate for basic
molecular biological research, they do not address adequately
concerns about industrial activity in this field. Moreover,
NIH currently does not have the resources to oversee the
commercial development of biotechnology products. It is
questionable whether taking on such a responsibility would
be consistent with the Institutes' mission.
Consequently, products arising from recombinant DNA
research, and the development of markets for these products,
is proceeding without clear regulatory oversight. In Du Font's
view, such oversight should be the responsibility of a govern-
ment agency or agencies with full regulatory powers. Leaving
biotechnology in a regulatory limbo subject to the uncertain-
ties inherent in lay review by our judicial system is
unacceptable.
Clearly, there is an expectation that the U.S. will
achieve commercial breakthroughs in biotechnology. It is our
view that Congress has been supportive of biotechnology and,
we understand has wanted existing agencies to oversee its
development in a manner that will not stifle either scientific
or industrial innovation, or compromise our current leadership
position opposite the strong competition we can expect from
other nations.
60
Several government agencies already have asserted
jurisdiction over biotechnology in their areas of administra-
tion. The Food and Drug Administration has jurisdiction over
drugs, devices and food additives. The fact that such are
genetically engineered organisms or are produced by genetic
engineering should not affect this jurisdiction. The EPA
has jurisdiction over pesticides. Again, the method of
action or manufacture of these materials should not alter
the established authority. EPA also has responsibility for
administering the Toxic Substances Control Act -- TSCA --
which gives it broad authority to regulate and monitor a
wide range of industrial products and processes. Thus, EPA
would also have jurisdiction over industrial application of
biotechnology relating to the manufacture of a chemical
substance. In addition, the Occupational Safety and Health
Administration has jurisdiction to regulate the workplace
and could fill any voids in the jurisdiction of other agencies.
Many of these agencies have already indicated that
they believe existing laws provide them with the authority
to regulate biotechnology and we do not challenge this.
However, no agency other than NIH has yet established
guidelines or protocols to deal with the special concerns
that revolve around the intentional release of genetically
engineered organisms into the environment. That is, no
other agency has expressed its approach to open air field
testing, development work or marketing of such products. And,
under the present circumstances, even the well-intentioned
61
efforts of the different agencies involved could quickly
become a collection of overlapping and redundant laws if
we are not careful.
To avoid this, there should be systematic coordina-
tion of regulation among the existing agencies. In our view
the principal activities should include the following:
• First, there should be clear expression of juris-
diction by the involved agencies, that is, it should be
proscribed which biotechnological products or processes fall
under each agency's unique jurisdiction. We understand the
Cabinet Council is encouraging such activity and we support
early action on this item.
• Second, the agencies should establish guidelines
based on the latest scientific information that would form a
consistent basis for administrative regulatory oversight.
• Third, the agencies must develop scientific
competence in biotechnology. Until this competence is
developed, the agencies should consult with RAC.
Developing an appropriate science base will be
particularly important for EPA since it appears likely that
the initial regulatory work will fall within the scope of
that agency. Of immediate concern is the future of experi-
ments that involve field testing of genetically engineered
organisms since such experiments are integral to the
development work of many academic and industrial laboratories
in this country. It is crucial that no time be lost in
39-383 O— 84-
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providing the guidelines necessary for carrying them out to
realize the benefits of such tests to our agricultural industry.
• Fourth, we recommend the establishment of an inter-
agency committee for biotechnology regulation assessment.
This committee would serve as a sounding board for those
subject to regulation, as well as environmental and other
citizen groups. It would hear complaints and suggestions
and be in a position to correct redundancies and overlap
among agencies. This committee should be established for
a specific term, and only reappointed to another term if
circumstances point to a continued need.
• Fifth, an eminent individual of impeccable scien-
tific creditials and administrative experience should be
appointed special counsel to the President on biotechnology.
This would provide the government with an independent spokes-
person who could make policy recommendations and comment on
regulatory developments with the assurance that his or her
comments would be heard at the highest levels of government.
The biotechnology counselor would also be in a position to
promote the expansion and funding of biotechnology research.
• Finally, we recommend that there should be a strong
commitment to maintaining the NIH Recombinant DNA Advisory
Committee to continue to oversee laboratory research. RAC's
proceedings represent an important intellectual and scientific
resource, and as new regulations are proposed it would be unwise
to attempt serious departure from the committee's precedents.
63
In closing, we believe that a clear statement of
federal agency position by each involved agency is essential
at the earliest possible time. This is necessary to give
direction to industry and to give assurance to state officials
charged with environmental and public health responsibilities
that public concerns are being addressed. In so doing, there
will be no need for regulatory initiatives at the state level
which, we believe, have a great potential for inconsistent
and potentially overburdensome approaches, and will distract
this emerging industry from its prime objectives. Therefore,
although we do not see the need for federal legislation at
this time, we do see a need for strong Congressional support
for the existing agencies, NIH, FDA, USDA and EPA, to promptly
establish oversight mechanisms to ensure that biotechnology
product developments are undertaken in a responsible fashion.
64
ENVIRONMENTAL CONSEQUENCES OF GENETIC ENGINEERING
MARTIN ALEXANDER
CORNELL UNIVERSITY, ITHACA, NEW YORK
The introduction of a radically new technology usually will have
a number of uncertainties associated with it. This is true of genetic
engineering, and it probably has been true of every markedly new tech-
nology, whether it was the use of fire by primitive societies, the in-
dustrial revolution of the nineteenth century, or the application of
nuclear energy to peaceful pursuits. The proponents of these technol-
ogies, probably in the past and certainly at present, argue for the
enormous potential benefits and the absence of uncertainties. These
proponents are undoubtedly among the best spokesmen for the benefits;
it is their field, and they know it best.
However, it does not necessarily follow that those that know a tech-
nology can also assess its risk. Is the industrial manager really the
appropriate individual to assess the impact of air pollutants emitted
from his industry? Is the chemist the most knowledgeable individual to
evaluate the possible human health problems arising from the widespread
use of chemicals? And, are the laboratory geneticists the most knowledge-
able evaluators of the environmental problems associated with the delib-
erate release of genetically engineered organisms? These individuals
know their technology and have much to offer to society by exploiting it,
but one should clearly distinguish their knowledge of how to make use of
a particular technology and the information needed to assess the risks
from what they plan to do. Genetic engineering is not at all unique in
this regard.
65
For the ecologist and the environmental scientist attempting to pre-
dict the risk of introducing new organisms into our environment, there is
a high degree of uncertainty in anticipating the consequences of genetic
engineering. Such an uncertainty apparently does not characterize many
laboratory-based geneticists and representatives of industry, who rarely
have an adequate base of information in ecology or in other environmental
sciences. This uncertainty, however, is found among many scientists
whose daily concern is the behavior of organisms in natural environments,
as well as in those man-controlled environments that we use for food and
fiber production. The degree of uncertainty surely is not reduced by
statements by specialists in other disciplines who maintain that, even
in the absence of data or convincing theoretical arguments, no problems
exist. Uncertainty is not equivalent to a belief that there is, or will
very soon be, a problem, but it is associated with a feeling that we are
progressing along a course of action that may lead to minor or major
problems, in the near or in the long term.
As an applied environmental scientist and a microbial ecologist con-
cerned with agriculture and chemical pollution, I am convinced that genetic
engineering has much to offer to society. I believe that we shall soon
witness the introduction into farming operations of microorganisms that
will result in better control of insects and improved growth of the plants
we grow for food and feed. New varieties of crop species will also be
developed by genetic engineering, and these will result in greater yields
and higher quality crops. Genetic engineering will also aid in our at-
tempts to improve animal production and to reduce the severity and fre-
quency of animal disease. In the area of chemical pollution, genetic
66
engineering probably will provide microorganisms that more rapidly or more
completely destroy a variety of pollutants in surface and groundwaters and
in industrial wastes. Thus, I believe that assessments of the possible. en-
vironmental consequences of genetic engineering must be approached in the
context of the many benefits to be derived from these research and industrial
activities .
If genetic engineering is indeed the wonderful technology that many of
us believe, it will be used in ever more numerous ways, and the various ap-
proaches currently being developed will be expanded to include a variety
of organisms, uses and environments. It has been stated frequently that
no problems have arisen with the few techniques and few organisms that have
been engineered to date, but the ever expanding scope of genetics and the
new areas for practical exploitation will take us far beyond the few tech-
niques and the few organisms on which genetic engineers have focussed their
attention. The technology is so powerful that an enormous amount of genetic
information will potentially be transferable to a vast array of different
organisms .
In this light, I, as an ecologist, am not too bothered by the lack of
information on the possible environmental consequences of the still infant
field of genetic engineering. However, I am enormously concerned by the
lack of a meaningful base of information to predict what might occur as the
science develops and industry becomes able to transfer an increasing amount
of genetic information from one organism to another.
Indeed, a review of other technologies indicates that there was little
or no hazard in their early stages. For example, during the initial develop-
ment of the chemical industry or at the time when the use of pesticides was
67
just beginning, Tittle or no hazard existed for society at large and no
threat was posed to major natural ecosystems, but as those technologies
became more widely used and moved in new directions, the environmental
and health problems became quite apparent. Thus, it is the ever growing
number of organisms and the diversity of techniques that will be used in
genetic engineering that increase the concern about our uncertainties and
our lack of information.
Natural environments have a variety of checks and balances that pre-
vent the many species and populations in our surroundings from being overly
abundant or doing major harm to other species. The various mechanisms that
are responsible for the balance among species in natural environments hold
in check the many pests and disease-bearing organisms that these environ-
ments contain. It is these very interactions that prevent most organisms
from one habitat from becoming established in another. These same mecha-
nisms probably will destroy most of the engineered organisms that are de-
liberately introduced, just as they have eliminated most organisms that
are transported from one environment to another. Because of these natu-
ral checks and balances, ecological or environmental upsets associated
with newly arrived or rare organisms are uncommon.
However, these ecological upsets do occur. They take place under two
circumstances. First, when the natural system of checks and balances is
upset, as commonly occurs when virgin land is cultivated, when the home-
owner plants a lawn, when a farmer uses large amounts of a pesticide, or
when a dam is built. Second, when species not previously present in an
environment are introduced into that environment. The establishment of
these so-called exotic species is known to have occurred for sparrows
68
and many other birds, the rat and mongoose among mammals, the gypsy moth
and many other types of insects, a host of plant species that are commonly
called weeds, and microorganisms that cause major diseases of agricultural
crops, trees, animals and even of humans. The successful establishment and
devastating effects of these dissimilar organisms is amply documented. Al-
though one might question the applicability to genetic engineering of our
knowledge of the harm done by exotic species introduced into environments
where they were not previously present, that information is much more use-
ful then untested and often unconvincing hypotheses about the lack of estab-
lishment or effect of an organism whose behavior in nature is totally un-
known. Thus, although the history of ecological, agricultural and public
health disasters has a questionable relevancy to a completely new technol-
ogy, the reliance solely on ecological theory expostulated by nonecologists
seems to be even more tenuous. Ecologists are embarrassed to admit that
they cannot predict whether a currently existing species will or will not
become established when introduced into a new environment. If ecologists
cannot make accurate predictions for existing organisms in a problem area
that is ecological, how can a nonecologist make a convincing statement
about a newly modified organism, one for which there is no environmental
experience?
What then are the areas of uncertainty? What should we know in order
to reduce the level of uncertainty arising from the planned, deliberate
release of engineered organisms? Five areas of ignorance stand out.
First, will the engineered organism survive? Obviously, if it does
not survive, it will pose no environmental, agricultural or public health
hazard, but likewise, a nonsurvivor would be of little practical interest
69
to industry because it would have little market value. On the other hand,
some organisms may persist only long enough to give the beneficial effect
for which the organism was originally engineered yet still sufficiently
long to pose a hazard. Such poor survival of many organisms that do in-
jury before they die is well known; for example, the bacterium that causes
cholera usually stays alive in nature for short periods, but its persist-
ence is sufficiently long to constitute a major threat to humans.
Second, will the organism multiply? For many species, the few indi-
viduals that endure do not constitute a problem in agriculture, ecology
or public health, but should they multiply and reach large populations,
major disturbances become evident. For example, the few seeds of a weed
species that may be released or the few individual insects that may escape
present no problem, but their multiplication could easily be the first phase
in a major upset.
Third, is the potentially deleterious genetic information transferred
from the deliberately released organism to other species? The microorga-
nism or higher plant that is released for the purposes of increasing food
production or promoting environmental quality may not endure, but those
traits that serve as the bases for concern might be passed to another or-
ganism in the same environment. In this way, injury might arise not from
the originally released organism but rather from another species that has
acquired the genetic information. Such gene transfer does take place and
serves, for example, as the basis for decline in effectiveness of certain
antibiotics used in medicine.
Fourth, is the engineered organism transported or disseminated to
new sites? Frequently, the area where an organism is first introduced
is not the place where it can do some harm. The original site may not
70
be receptive to its growth, or plants and animals that it may injure may
not be located in the vicinity. Many microorganisms and plants fail to
be transported for any distance from the point of their original discharge,
but other species are widely dispersed and soon appear at considerable
distances from the point of their first introduction. For example, micro-
organisms in a short period of time may be transported for tens, hundreds
or thousands of miles, and farmers noting the spread of weeds and allergic
humans also can attest to the capacity of plant seeds and pollen to move
for considerable distances.
Fifth, will the introduced organism have a deleterious effect? This,
of course, is the critical question, but answers to that difficult ques-
tion do not have to be sought unless the engineered organism survives for
an adequate period of time, is able to multiply, and can move from the
place of its introduction to the place where it may do harm. It is my
belief that most genetically engineered organisms will not pose problems
because most will not survive, most that survive will not multiply, gene
transfer is reasonably infrequent, most that survive and multiply will
not be transported to a distant place, or most transported organisms will
not have the traits needed to cause injury. The fact that most engineered
organisms will fail one of these tests does not mean that all will. Which
organisms will fail one or more of these environmental tests cannot now
be predicted.
Indeed, our knowle dge is so limited that it is not eve n possible to
state the characteristics that result in failure or succe ss. Large un-
certainties exist in anticipating the environmental consequenes of genetic
engineering because of these major knowledge gaps. Consider the case of
71
survival. Some attention has been given to the issue of survival of intro-
duced but not of engineered organisms, and it is known that many microorga-
nisms that cause diseases of humans, animals and plants and many introduced
plants and animals fail to survive when introduced into an environment where
they do not presently exist. However, some of these introduced organisms
do indeed endure. With the little attention given to determining the basis
for successful or unsuccessful establishment, it is not possible to provide
meaningful predictions of whether a new organism will or will not survive
i n nature.
Consider the issue of multiplication. Surprisingly little attention
has been given to explaining why some species multiply in nature, whereas
others do not. This is especially true of the types of microorganisms
that are likely to be the subject of genetic engineering. Microorganisms
as a class multiply in soils and waters, on plants, and within the bodies
of animals, but we can rarely say whether a particular microorganism will
multiply in nature. Such evaluations are simple to conduct, and the ab-
sence of information is simply a reflection of the lack of attention given
to the problem, either by researchers or by regulatory agencies.
Attention has been given to the possibility nf nene pyrhar|qp in nal^nre^
however. Laboratory tests of microorganisms, for example, suggest that
genetic information may be exchanged in soils or waters, but even this in-
formation is limited and usually comes from studies under highly artificial
conditions and with traits that are not of environmental importance.
We also have considerable information on the dissemination of orga-
nisms from one site to another. This knowledge comes from monitoring the
spread of human, animal and plant diseases and, to a lesser extent, from
72
basic studies in biology. The available information shows that certain
microorganisms and plants are transported enormous distances, and the
spread of disease, the dispersal of pollen and the transport of a variety
of microorganisms is amply documented. Nevertheless, even with this ample
data base, few of the attributes that make microorganisms more or less sus-
ceptible to dissemination are known, especially among the species of likely
interest to genetic engineers. Hence, predictions of the dispersal of a
new organism cannot be made with any degree of confidence.
Uncertainty thus exists on whether an introduced organism will survive,
multiply, transmit its genetic information and be transported to a site to
where it may have an effect. Can we predict its potential for doing harm?
The information on ecological upsets and on diseases of plants, animals and
humans is abundant. Enormous numbers of human deaths have resulted from
the introduction of microorganisms into regions where the people were not
previously exposed to the harmful agent, and the decimation of the popula-
tion of Indians in North and South America and of the original inhabitats
of the Pacific islands bears witness to the susceptibility of previously
unexposed populations. The responsible microorganisms were not deliberately
modified genetically, but simple genetic changes that have occurred and do
still occur in nature have been the prelude to major human diseases, as with
the virus causing influenza. These genetic changes may not be too different
from those that are currently of interest in genetic engineering. Agricul-
tural crops have also often been devastated following the introduction of
a new disease agent, and many of these disease-producing microorganisms are
genetically very similar to species that previously had little effect on the
farmer's crop. Various mammals, harmful rodents, plants that we now term
73
noxious weeds and other species have successfully overcome the barriers to
establishment that exist in nature, and they have had major impacts on their
surroundings.
It is my belief that the probabilities of survival, multiplication,
gene transfer, dispersal and detrimental effects are quite small, and
therefore, the probability of the final event in the sequence is even
smaller. Nevertheless, I do not know how small is a small probability.
Moreover, as genetic engineering uses new techniques, is applied to more
organisms and is more widely used, an event that may take place one time
in a thousand will occur because the type of event has been repeated one
thousand times. Let me stress what I believe is a crucial point: in the
absence of a substantive body of scientific information to allow for re-
liable predictions, and in the absence of data from tests designed to
provide information on individual genetically engineered organisms, it
is utterly foolhardy to anticipate what may, or may not happen, in nature.
The uncertainties on the possible environmental consequences exist
because of the paucity of information on the ecology of organisms related
to those of current or likely future importance in genetic engineering.
Scientists notwithstanding, uncertainties will remain even as we gain
more information, but at least the degree of uncertainty and presumably
the likelihood of a problem arising will be substantially reduced as the
information is obtained. The degree of uncertainty can also be reduced
by data from appropriate tests mandated by a regulatory agency. Even
with a wealth of scientific data, testing is important because science
provides generalizations, guidelines and approaches, but exceptions to
the rule are not exceptional. Science can reduce but surely not eliminate
74
the uncertainty. Hence, it is essential that a regulatory agency require
a meaningful but not onerous series of tests to evaluate potential hazards.
These tests would allow that regulatory agency to go beyond the generaliza-
tions derived from scientific inquiry and should permit an evaluation of
potential problems not revealed by our generalizations.
I am excited by the prospects and benefits of genetic engineering.
I am also impressed by how little we know of the potential behavior of
deliberately introduced organisms. I believe that the considerable un-
certainties that remain among scientists trained to understand the be-
havior of organisms in nature can be reduced very markedly. This can be
accomplished by research designed to predict the behavior of organisms
introduced into environments in which they are not native and by regula-
tions that require industry to provide information to allow for assessment
of safety or hazard. In this way, I believe that we shall be able to gain
the benefits of an extremely important new technology while minimizing the
risk to humans, agriculture and our environment.
75
Title: Safety Concerns Regarding Genetically Engineered Plants
and Microorganisms to Benefit Agriculture
Author: Winston J. Brill
Phone: (608) 836-7300
The author is Vice President of Research and Development, Agracetus, 8520 University
Green, Middleton, Wisconsin 53562, He is also Adjunct Professor of Bacteriology,
University of Wisconsin.
76
SUMMARY
Predictions regarding the safety of a recombinant plant or microorganism for
agricultural use should be based on our vast experience with traditional practices such as
plant breeding and use of microbial inoculants. An introduced plant, bacterium or fungus
containing foreign genes should present no greater environmental damage than such
organisms without recombinant genes. Problems caused by introduction of foreign
organisms such as kudzu vine and gypsy moth should not bear on safety predictions of an
organism, currently considered safe, that has several characterized recombinant genes
added to its genome.
77
Federal agencies are considering types of regulation needed to protect the public from
possible environmental and health problems that might arise from the release of
genetically engineered organisms. Concern has been expressed because several
agricultural practices, such as widespread use of DDT over past decades, have caused
serious problems. Also, movement of weeds and insect pests into new environments
have created problems that have become difficult to control. Examples include the
kudzu vine, hydrilla, gypsy moth, and Japanese beetle. Because of these experiences, it
is necessary to consider potential effects from the release of organisms containing genes
from unrelated genera. This article will focus on the use of genetically engineered plants
and microorganisms (bacteria and fungi) to benefit agriculture. Other applications, to
which the same principles should hold with regard to safety issues, include the use of
genetically engineered organisms for mining and detoxifying chemical wastes and spills.
Economic and environmental benefits expected from agricultural use of recombinant
organisms are great but these should be considered in relation to potential risks. By
splicing foreign genes into plant chromosomes, it may be possible to create plants
resistant to a wide array of pests. The hope and expectation is that they will lead to
decreased use of chemical fungicides and insecticides, many of which are toxic to man.
Use of recombinant DNA techniques may permit development of plants that utilize
fertilizers more efficiently, thereby minimizing fertilizer run off into streams and
lakes. In many crop species, a relatively narrow base or germplasm is presently used to
develop varieties. There is concern that this has created genetic vulnerability to disease
in particular. Genetic engineering can be used to introduce new genes and thereby
increase genetic variability for the future.
Genetically engineered bacteria and fungi also have potential value. For example,
Rhizobium strains isolated from many locations around the world are being applied to
soils in large numbers so that legumes (e.g. soybean, alfalfa, clover), produce high yields
without needing expensive nitrogenous fertilizers. Several approaches are currently
being used to increase legume yields with genetically engineered Rhizobium. Other
microbes also are promising candidates for use in agriculture (e.g. mycorrhizae,
Pseudomonas, and Frankia) , and there is a good chance that the value of these organisms
can be increased through recombinant DNA technology as well as through traditional
mutation and recombination techniques. As in traditional agriculture, the value of the
new plants and microbes can only be assessed after they have been tested under a variety
of field conditions. This report will focus on ways to predict the safety/danger level of
an organism that has received several foreign genes.
PLANTS
Plants have been crossed (traditional "genetic engineering") by man for centuries. New
variants resulting from such breeding have generally not been a problem. Most of our
high-yielding crops, productive forest trees, popular ornamentals and garden plants have
been derived through breeding programs. Some crosses include those that would not
occur without man's intervention. Crosses in the U.S. between high-yielding
midwestern U.S. corn and its wild ancestor, teosinte are examples. Species that do not
cross-pollinate have been crossed without recombinant DNA technology, by many
scientists around the world. Oats is a good example. Cultivated oats have been crossed
with a number of wild species to increase protein concentration of seeds and to introduce
resistance to diseases. Protoplast fusion between cells of plants that normally are unable
to cross have yielded new variants. Also, plants obtained by mutation have frequently been
planted in experimental fields with the hope of detecting useful new phenotypes. These
experiments produce novel plants and, with the exception of mutated plants, the progeny
are the result of uncontrolled recombination of tens of thousands of genes. The exact
properties of progeny from most of these crosses are impossible to predict. Breeders do
not take special precautions in testing these plants in the field because they rely on vast
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78
experience that has not produced serious problems. Compare plants derived from
breeding programs with those derived through genetic engineering. In the latter case, a
few characterized genes are added to the plant resulting in plants with properties
relatively easy to predict.
One ecological concern is the inadvertent release of a new weed plant that will be
difficult to control. However, the long and diverse experience of breeders and plant
geneticists indicates that genetic crosses among non-weedy plants will not result in a
problem. As we understand more about the genetic and biochemical basis of competition
by weeds, it is obvious that a large number of reactions/genes must interact
appropriately for the plant to display the properties of a weed (e.g. efficient seed
dispersal, long seed viability, rapid growth in an environment not normally favorable to
other plants). It is possible that hundreds or thousands of interacting genes are necessary
for a plant to be a problem weed. Thus, the chance that a cross between non-weeds will
yield a problem weed is expected to be exceedingly small. Most commercial field tests
with genetically engineered plants will involve cultivated crops that have been
specifically bred for high yield under intensive agricultural practices. As the crops are
bred for characteristics favorable to agriculture, the competitive properties are
weakened. Such crops, if left unattended, are not capable of competing well with other
plants. Addition of a few foreign genes to these crops should not produce an undesirable
weed.
Obviously, if weedy species are to be purposely genetically engineered, both the weed
and recombinant derivative need to be considered in light of potential environmental
damage. Whatever level of caution is currently used by scientists, who purposely plant
weeds, seems to be sufficient for weeds that have incorporated foreign genes. Genetic
changes in weeds, through man's activity, have occurred prior to application of
recombinant DNA technology. Over the last decades, the use of certain chemical
herbicides have caused uncharacterized genetic changes by which weeds have become
herbicide-resistant. Any problems have been overcome merely by using a herbicide to
which the weed is not resistant, thus removing the environmental pressure for
maintenance of the resistance genes.
There is a very small chance, through genetic engineering with uncharacterized genes,
that the resulting plant may produce a toxic secondary metabolite or protein toxin. For
this reason, animal feeding experiments might be desirable before an edible crop is
introduced commercially. Even through traditional breeding, however, toxin production
can be a concern, especially when exotic plants are used in the breeding program. A
good example is the high solanine content of potato varieties that had to be removed
from the market. Several plants currently marketed have toxins (e.g. rhubarb, cotton,
castor) and therefore need to be carefully processed. Plant toxins, whether polypeptide
or secondary products, should be rapidly degraded and not accumulate in the soil or water
supply.
There have been problems caused through traditional breeding, and those types of
problems are expected to occur from plants arising from genetic engineering. For
instance, certain popular corn hybrids turned out to be especially susceptible to the
fungus, Helminthosporium. This resulted in the corn blight which destroyed a large
portion of the U.S. corn crop in the early 1970's. Breeders are trained to be alert for this
type of situation however. They had lines ready to quickly replace the ones susceptible
to corn blight. Field tests, therefore, are necessary to assess the threat of pathogens and
to check for undesirable characteristics of new varieties, whether they are products of
traditional breeding or of genetic engineering.
One of the reasons that critics urge caution with regard to environmental release is
79
experience with problem plant species such as kudzu vine. This plant has been extremely
difficult to control after its introduction in the southern U.S. Deliberate release of
plants produced by breeding or genetic engineering bears no relevance to problems
caused by importing certain foreign organisms. Those problems were not caused by
changes in the genetic make-up of the plant, but rather by its introduction into a new
environment. The species evolved over eons to be competitive (that is why it exists
naturally in at least one environment). In that natural environment, a variety of factors
such as other plants, pests and weather kept the population in check. It is important to
realize that it is only a rare introduced species that causes problems. The majority of
U.S. -grown crops were initially introduced from other parts of the world. The U.S.D.A.
maintains large collections of wild members of our cultivated species to improve our
crops. These collections are not normally maintained under strict quarantine.
MICROORGANISMS
Even though fungi and bacteria are very different than plants, similar types of analogies
regarding safety can be made. From the early years in this century, certain microbes
were grown in large volumes and, in many cases, became the bases of new industries.
Examples include antibiotic, solvent, vitamin and amino acid production. Scientists have
not been concerned that escape of these organisms will create an environment or health
problem that is difficult to control. This lack of concern is based on scientific
experience and the common observations of microbial behavior in the environment. A
culture of or billions of cells of an uncharacterized microbe is added to the environment
every time uncharacterized "microbial cultures" (e.g. a rotting orange) are added to the
environment. Microbiologists are not concerned that such uncharacterized organisms
will cause a difficult-to-control problem. In the last few decades, many pure cultures of
bacteria and fungi (inoculants) have been added to soils or plants in the environment with
the hope of finding useful applications; for example, oil and chemical waste removal,
wood and straw decomposition, plant pest protection or plant growth stimulation.
Mutant strains of such organisms also have been added to the environment. Again, no
substantiated damage of significance has been caused through these practices.
There is no reason to think that a bacterium or fungus that is not known to damage the
environment will cause environmental problems after it has obtained several
characterized foreign genes. That a dangerous organism in the soil (e.g., Clostridium
tetani) will become more of a problem after acquiring these new genes, from the
introduced organism, also is remote. Certainly, microorganisms intentionally and
unintentionally added to the environment have naturally exchanged genes with other
microorganisms. Such organisms have moved through wind and water, as well as through
man's travel, to distant places. Microbes without man's intervention, are continually
sharing and rearranging genes through transposons, viruses, plasmids, etc. Random
microorganisms generally are unable to predominate in new habitats because preexisting
organisms already have evolved to successfully compete for these niches. In most cases,
a microbe in nature grows far more slowly than it does in laboratory cultures; thus the
newly introduced organism will probably have a difficult time surviving and an even more
difficult time significantly increasing and maintaining its population, whether genetically
engineered or not.
What is the chance that a harmless microorganism can become a pathogen after it has
been genetically engineered to be agriculturally useful? Studies with pathogens have
demonstrated that many genes with interacting activities (usually not all linked to each
other) are required for a microbe to cause disease, persist outside of the host, and be
transferred to subsequent hosts. Most of these studies involved animal pathogens, but it
is becoming apparent that the same is true for plant pathogens. The chance that one
80
could accidentally convert a microbe that normally is non-pathogenic to become a
problem pathogen through introduction of characterized foreign genes seems to be very
unlikely. Appreciation of this should minimize concern over problems with natural
dynamic microbial gene exchange among uncharacterized microbes in the field.
Examples are known from current practices in which acquisition of a single gene or a
mutation in a microbe might cause ecological problems. Paradoxically, genetic
engineering may be able to help in addressing those cases in which agricultural practices
have had adverse environmental impact. Current applications of certain herbicides or
pesticides to soils enrich the soil for microbes that degrade the chemical, resulting in the
need to apply more of the chemical in subsequent years. Another example is aquisition
of antibiotic-resistance genes that have caused major medical problems. These problems
arose, not by man's ability to genetically manipulate organisms but, rather, by
introducing chemicals to the environment. The problems can be reversed by eliminating
application of such chemicals. In fact, some current genetic engineering experiments are
focused on projects expected to decrease the use of many industrially produced
chemicals.
NEED FOR FIELD TESTS
To allay concerns regarding the safety of a recombinant organism, it would be useful to
follow testing protocols before the organism is released. However, the task of designing
relevant tests for most situations seems to be enormous, if at all achievable. How would
a greenhouse test show that a corn line resulting from a standard genetic cross will not
become susceptible to a fungal disease or become a problem weed? If a bacterium
increases corn yield in the greenhouse, how will we guarantee, without field testing, that
it will not unexpectedly harm the following season's crop? Tests aimed
towards predictions of microbe persistence level in a field could be very difficult and not
relevant. Because different soils, soil treatments, and weather conditions can alter the
growth rate and persistence of a microbe, greenhouse or growth chamber experiments
probably have little relevance to field results. Experience with current field testing
practices seems to be the best guide to predict safety.
Certain microorganisms and plants have been introduced in the environment without need
for regulation. Such organisms containing recombinant DNA should not be of concern
unless the introduced genes have obvious potential problems (e.g. botulinum toxin gene)
which require special precautions. It is unlikely that such experiments would be proposed
for field testing. Because of the complex interaction of genes required for an organism
to cause disease or environmental disruption, it would be extremely difficult to purposely
engineer an organism now considered to be safe to become an organism that would spread
a significant problem. A program that aims to utilize, in agriculture, a plant, bacterium
or fungus considered to be safe, but with several foreign genes, should have essentially no
chance of accidentally producing an organism that would create an out-of-control
problem. The chance and severity of a problem from genetic engineering should be
compared to known problems from current genetic and chemical practices such as
breeding and use of chemical pesticides. Regulation over release of genetically
engineered organisms should be based on scientific experience and debate of the issues.
This article, hopefully, will be used as a stimulus for debate.
THE POTENTIAL ENVIRONMENTAL
CONSEQUENCES OF GENETIC ENGINEERING
THURSDAY, SEPTEMBER 27, 1984
U.S. Senate,
Committee on Environment and Public Works,
Subcommittee on Toxic Substances
AND Environmental Oversight,
Washington, DC.
The subcommittee met, at 10:10 a.m., in room SD-406, Dirksen
Senate Office Building, Hon. Dave Durenberger (chairman of the
subcommittee) presiding.
Present: Senator Durenberger.
OPENING STATEMENT OF HON. DAVE DURENBERGER, U.S.
SENATOR FROM THE STATE OF MINNESOTA
Senator Durenberger. The hearing will come to order.
Good morning everyone. Today is the second day of hearings on
the potential environmental consequences of genetic engineering.
We indicated on Tuesday the topic is a difficult one. The technol-
ogy itself is new and little understood by the lay public. It does
have a certain science fiction quality to it. The term itself, genetic
engineering, sounds a little Orwellian.
But laying aside any vague and unfounded fears of modern sci-
ence, I believe we are correct in approaching the new genetic engi-
neering technologies with prudent caution. We learn from experi-
ence. We embraced without question the burgeoning chemical in-
dustry after World War II, and in retrospect we should have been
more skeptical. We should not have been so dazzled by the promise
of better living through chemistry that we failed to anticipate in-
jection wells, waste dumps, and a lot of other topics that have occu-
pied our time incessantly in the last several years.
I think there is an analogy with genetic engineering. We are in a
period of dramatic innovation in techniques and products. Those
persons most closely associated with this innovation assure us that
enormous benefits will come from it. I do not dispute that. But we
also must look ahead to the potential harm that might result and
do whatever we must do to prevent that harm. It is a tricky ques-
tion: how to get at the benefits of genetic engineering while avoid-
ing the risks.
Witnesses we have heard so far have tended to agree that the
risk of harm from releasing genetically engineered organisms is
small, but that it does exist. I understand today we will hear about
some of the possible secondary effects of these technologies as well.
(81)
82
The question is one of dealing with uncertainty. And here the
opinions we have heard thus far diverge rather sharply. One line of
reasoning is that genetic engineering is merely a more precise way
of developing a hybrid corn or a shorthorn steer. Nothing to worry
about.
The other line of argument is that we are beginning to tamper
with the fundamental blueprint of life in ways that are qualitative-
ly and quantitatively different from the practices of the past, and
we had better proceed cautiously because we do not know enough
about how ecosystems work to know the consequences of this kind
of intervention.
I do not expect that today's witnesses will extricate us complete-
ly from that quandry. But I hope they can shed some additional
light on the questions I put forward on Tuesday: First, does genetic
engineering present the possibility of significant harm to the envi-
ronment? And second, is the existing patchwork of statutes, regula-
tions, and guidelines adequate to prevent any potential problems?
In conclusion, I need to note that one of our scheduled witnesses,
Mr. Thomas McGarity, is unable to be with us today due to an ill-
ness in his family. However, we have received an excellent written
statement from Mr. McGarity. It will be made a part of the record.
(See p. 114.)
Let me then ask all four of our witnesses to come to the witness
table: Dr. David Jackson, senior vice president and chief scientific
officer, Genex Corp.; Dr. Daniel S. Simberloff, Department of Bio-
logical Science, Florida State University; Mr. Jack Doyle, director,
agriculture resources project. Environmental Policy Institute; and
Mr. Jeremy Rifkin, president, the Foundation on Economic Trends.
We welcome all four of our witnesses. Your written statements
will be made part of the record of this hearing.
You may proceed. We will start with Mr. Jackson.
Our rules are stay as close as you can to a 10-minute summary of
your statement. We will take the statements of all the witnesses
before we proceed to the questions.
STATEMENT OF DAVID A. JACKSON, SENIOR VICE PRESIDENT
AND CHIEF SCIENTIFIC OFFICER, GENEX CORP.
Dr. Jackson. Thank you very much, Senator Durenberger.
I would like to make a series of points in my testimony this
morning. Let me tell you in outline form what they are going to be.
The first is that I believe that regulatory action regarding the
products of biotechnology, including genetic engineering, should be
directed toward the properties of these products and not to the
technology which is used to produce the products. I believe that the
focus of the present debate on genetically engineered organisms, as
opposed to organisms, however they have been produced and what-
ever their properties may be, is misleading and will be counterpro-
ductive in a regulatory context.
Second, and following directly from the first, I believe that main-
tenance of the focus on whether an organism has been produced by
genetic engineering or not will lead to inconsistent and ultimately
indefensible regulatory policies.
83
Third, I would like to argue that the existing regulatory agencies
and the statutory authorities which underlie them are an appropri-
ate base from which to regulate products made using biotechnol-
ogy, including genetic engineering, and that no new agencies are
needed. However, I do think the existing agencies need help.
The fourth point I want to make is that a ban on all controlled
introductions of genetically engineered organisms into the environ-
ment would be counterproductive both scientifically and as public
policy, assuming that it is in the interest of this country to com-
mercialize biotechnology in a responsible way and to preserve our
lead relative to other countries in this extremely important tech-
nology.
Fifth, I would like to suggest that we have a very relevant histor-
ical paradigm for the present debate over information of genetical-
ly engineered organisms into the environment. This paradigm is
often referred to as the Asilomar process. It occurred in response to
a similar controversy in the mid-1970's concerning potential bioha-
zards of genetically engineered micro-organisms. I think that the
Asilomar process has a lot to teach us, and I hope we can learn
from that illuminating experience.
Let me now elaborate on these points.
The first point I made is that the focus on genetic engineering is
something of a "red herring." Many people believe that an orga-
nism that has been modified by genetic engineering is somehow
wholly different from normal organisms or from variants of normal
organisms which are obtained by conventional genetic mutation
and selection programs or by conventional breeding programs,
techniques that have been used by man for the genetic manipula-
tion of his environment for thousands of years. In contrast, I would
assert that it is simply incorrect to conclude that genetically engi-
neered organisms are somehow a fundamentally different class of
organism. It is true that it is possible to construct organisms using
genetic engineering techniques which are modified in ways that
could occur at most very infrequently in nature. But it is also possi-
ble to use the same genetic engineering techniques simply as an al-
ternative and much more efficient means of constructing genetical-
ly modified organisms which were previously constructed by con-
ventional genetic means.
In this latter case, it is perfectly possible that two different orga-
nisms, one produced by genetic engineering methods, another pro-
duced by what we would call conventional genetic methods, could
turn out to be literally identical. In such a case I think it would be
very difficult to argue that one organism should be regulated dif-
ferently from the other, simply because a particular set of tech-
niques had been used to construct it.
So, I present this argument to focus attention on an extremely
important point: A rational regulatory policy regarding release of
organisms into the environment must focus on the properties of the
organisms and the products they make, not on the processes by
which the organisms were modified. After all, it is the characteris-
tics of an organism, not the techniques by which those characteris-
tics were modified, which will be responsible for any environmental
impact the organism may have.
84
Let me turn now to the second point, which is related. It is that
if we do continue to focus on whether or not an organism is geneti-
cally engineered rather than on what its properties are, then we
will get ourselves into a difficult situation, certainly with respect to
a consistent regulatory policy.
I think the current controversy regarding the field testing of the
so-called ice-minus bacteria, which I am sure you have heard about
at great length at these hearings, can be used to illustrate this
point. As you know, ice-minus bacteria are variants of either of two
species of micro-organisms, Pseudomonas syringae and Erwinia
herbicola, which lack the ability of the parent microorganisms to
promote the formation of ice crystals in supercooled water. The ice
nucleation activity of the parent micro-organisms is responsible for
a substantial amount of the frost damage done to crops by tempera-
tures somewhat below the freezing point, generally between about
24 and 28 °F.
These ice-minus variants, which occur naturally or which can be
produced by modifying the parent micro-organisms using either ge-
netic engineering techniques or conventional mutagenic tech-
niques, do not promote frost damage on plants they colonize. Also,
of course, if these ice-minus variants are sprayed on the plants at
appropriate times, they are able to reduce the population size of
the ice-nucleating parent micro-organisms to the point that frost
damage is substantially reduced.
I do not think there is very much dispute about any of what I
have said so far. The information about ice nucleation properties of
these micro-organisms and their genetic variants has been obtained
from experiments using naturally occurring ice-minus variants in
laboratories, greenhouses, and, I wish to emphasize, in field trials
in the case of naturally occurring ice-minus variants. Experiments
with genetically engineered ice-minus variants in laboratories and
greenhouses have confirmed that these organisms behave in the
same manner as the naturally occurring ice-minus variants under
those conditions. But, as of course you know, field trials of the ge-
netically engineered variants are much in dispute and are present-
ly prohibited.
The ostensible reason for urging prohibition of field trials of the
genetically engineered ice-minus variants is that their effects are
unknown and might be damaging to the environment. I think one
is forced to conclude, however, that the real reason prohibition has
been sought in this case is that the organisms are genetically engi-
neered. As mentioned above, field trials with naturally occurring
ice-minus variants, which have similar, if not identical, physiologi-
cal characteristics to the genetically engineered versions, have al-
ready been performed. So far as I am aware, there have been no
claims of any harmful effects arising from these field trials. More-
over, there is no prohibition on repeating these trials with an orga-
nism which has been modified by conventional techniques rather
than by genetic engineering.
I believe that situations as obviously inconsistent as this make
for bad regulation. If ice-minus bacteria are harmful to the envi-
ronment, they should not be placed in large quantities into the en-
vironment, irrespective of how they are prepared. Similarly, if they
85
are not harmful to the environment, the fact that they have been
prepared using genetic engineering techniques is immaterial.
Finally, I think it is worth noting that other biological tech-
niques for reducing the damage caused by Pseudomonas syringae-
promoted ice nucleation have also been developed. One of these
techniques involves spraying crops with suspensions of bacterial vi-
ruses which grow on these naturally occurring organisms. These
naturally occurring viruses, in killing a whole population of bacte-
ria, undoubtedly introduce an ecological perturbation, and probably
a significantly larger one than the introduction of ice-minus bacte-
ria which differ from normal micro-organisms by only one or a few
genes.
I want to emphasize that I am not here taking a position as to
the relative safety or efficacy of the various biological approaches
to dealing with crop damage promoted by ice-nucleating bacteria.
What I am saying is that safety and efficacy should be the basis for
regulatory action, not the mechanisms by which the organisms
have been modified, unless, of course, those mechanisms can be
demonstrated to affect safety and efficacy.
Let me now turn to my third point. It is that I believe that the
existing regulatory agencies are an adequate basis for a consistent,
evenly applied policy of regulation for the products produced by
biotechnology. Most of the products which will be produced by bio-
technological processes will fall under the regulatory purview of
one of three agencies: FDA, EPA, or USDA. These agencies have a
long history of regulatory expertise and they have the statutory au-
thority to be able to regulate products in these areas.
The FDA has developed considerable competence and sophistica-
tion in the subject of genetic engineering and products which result
from utilization of that technology. The EPA is clearly aware of
the fact that it needs to develop such competence and is moving in
that direction. However, my judgment is that the EPA certainly
needs additional help in the form of additional personnel who are
expert in such fields as microbial ecology and molecular biology in
order to gain the internal competence they will need to develop
and implement a rational regulatory policy for the many new prod-
ucts made possible by biotechnology which will fall into the agen-
cy's regulatory domain.
I think there is also a question as to how best to use all of the
resources of the Federal Government in the next several years
while the regulatory agencies are developing their own internal ex-
pertise. Here I would suggest that a body already exists, the Re-
combinant DNA Advisory Committee [RAC], which could usefully
make its expertise available to the various regulatory agencies. I
cannot suggest how structurally within the Government one ought
to make this competence available. However, I would suggest that
functionally the situation that one would like to create is to utilize
the competence of the RAC, which I think has real expertise in cer-
tain areas and lacks expertise in other areas dealing with the regu-
lation of genetically engineered products and organisms, and sup-
plement that competence of the RAC with people both from outside
the Federal Government and from within the relevant regulatory
agencies.
86
As I say, I cannot really make a recommendation as to how to
achieve this goal in a structural sense within the Government, but
functionally it seems to me that getting the RAC together with
people from FDA, EPA, USDA, along with some people from out-
side the Government, particularly in the area of environmental sci-
ence, could then produce a very important nucleus which could be
used to help all of the agencies deal with the flood of decisions
about biotechnology products which is bearing down on them.
Let me now turn to my final point, which is the historical para-
digm from which I believe we have much to learn.
Back in the mid to late 1970's, there was considerable concern
about the possibility that genetically engineered micro-organisms
could infect people and animals and do so in a way that would be
very difficult to control. A conference held at Asilolmar, CA, was
convened to examine these questions. From the Asilomar Confer-
ence, helped subsequently very much by the leadership of Don
Frederickson at the NIH, came a way of dealing with questions of
unknown biological hazards that is something I think we ought to
look at carefully.
Basically, I think what we learned from that experience is the
following. The first lesson is that scientific input from many disci-
plines is extremely important in considering these questions. I am
a molecular geneticist, but I would certainly not argue that molec-
ular geneticists have all of the answers that are required to inform
responsible regulatory policy in this area. I think we have to get
people in who are expert in environmental sciences. We have to get
people in with public health expertise. We need to be able to draw
on the relevant expertise of soil scientists, water scientists, and at-
mospheric physics scientists. Indeed, I would argue that the Asilo-
mar experience teaches us that it was not until the molecular ge-
neticists and biochemists involved in the discussion specialists in
infectious disease, epidemiology, and public health, that a lot of the
noise that in resolving some of the most controversial questions
hindered real progress got quieted down. It got quieted down be-
cause these people had the facts that were necessary to say what
was real and what was not.
The second important point that we learned from the Asilomar
experience is that it is relatively easy to set up scientific para-
digms, experiments that can be used to test the underlying assump-
tions for some of the more horrible sorts of scenarios which were
being put forth at that time. Those experiments were done under
carefully controlled conditions in a period of about a year to a year
and a half after the debate really heated up. What they showed
was that indeed a lot of the assumptions that underlay the scenar-
ios that predicted a great deal of harm were simply not valid and
could be experimentally documented not to be valid.
Those results reassured many people, including a lot of people in
the molecular biology community whose intuition had told them
the potential problems were being greatly exaggerated, but who
really could not prove that their intuition was correct. The bottom
line is that it is always useful to do the experiment and get some
real data, instead of continuing to argue on the basis of different
mtuitions. Fortunately, it is often rather simple to identify and
perform a few key experiments, the data from which can clarify
87
whole sets of major questions and which can thus provide the basis
for intelUgent future action.
Finally, I think what the Asilomar experience showed us is that
we cannot insist on zero risk. We have to be willing to accept some
risk. A scientist has to be able to get additional data which will
provide the basis for greater certainty about risk and safety. The
only way of getting such data is by performing experiments. By
definition, one does not know how an experiment is going to come
out ahead of time. So one has to be able to accept some small meas-
ure of risk in order to get the information that will make it possi-
ble to construct and implement a public policy that is rational and
one which is based on intuitions and emotions. We should be get-
ting on with the job of identifying and performing the key experi-
ments relating to large-scale release of genetically modified orga-
nisms into the environment so that a regulatory policy having a
sound factual base will be possible.
Thank you.
Senator Durenberger. Thank you very much, Dr. Jackson.
Dr. Simberloff?
STATEMENT OF DR. DANIEL S. SIMBERLOFF, DEPARTMENT OF
BIOLOGICAL SCIENCE, FLORIDA STATE UNIVERSITY
Dr. Simberloff. I want to thank you for inviting me to testify at
this subcommittee.
I am an ecologist. My expertise is in the organization of ecologi-
cal communities — how animals, plants, fungi, microbes, et cetera,
function together in nature.
There is a popular image of nature, called the balance of nature,
that pictures communities as stable, saturated entities, with all ec-
ological niches filled and no room for new organisms — either new
genetic types of native species or new species from elsewhere.
In this view, natural communities are robustly organized, with
each species held in check by its interactions with predators, para-
sites, disease and competitors. So in this view a new organism
would be very unlikely to be able to insinuate itself into a commu-
nity. There would be very few resources available for it. It would
not be adapted to deal with the many enemies that it would en-
counter.
Unfortunately, ecologists have amassed lots of evidence that that
is not really the way nature is organized and that if the right ge-
netic type of a native species or the right introduced species hap-
pens to come along, it is able to fit into a community, even though
it might be to the detriment of some original species.
I have heard the claims that introduction of a new species is not
a good analogy for the release of genetically engineered organisms,
on the grounds that genetically engineered organisms are native
species, so they will be subject to all the controls from various
interacting species and the environment that they have evolved
with through the ages, and so they are much less likely to become
problematic than are introduced species.
To me this seems to be a very false dichotomy. In either case, the
community will have to deal with the new entity. It doesn't matter
to the community exactly how that entity arose. There is not even
88
any valid evidence that introduced species are on average more
harmful than new genetic strains of native ones. But just to be
very conservative, I would like in a moment to give you some ex-
amples of native species that have undergone relatively minor ge-
netic changes and have very rapidly become major pests.
But before I begin, I would like to point out that some of the ge-
netic enqineering research that is currently underway is aimed at
bringing about exactly the sort of change that in the past seems to
have released native species from some sort of control and ren-
dered them a real problem.
For example, there are now attempts to increase the resistance
of plants to insects and disease. There are attempts to increase the
geographic range or the virulence of diseases of insect pests, to
extend the range of physical conditions and sometimes chemical
conditions that will allow plants to grow, and attempts to broaden
the range of substrates that will support the growth of micro-orga-
nisms.
Some examples of native species that have become pests because
of minor genetic change come right to mind. One that is obviously
topical is the bacterial canker that is now threatening the State of
Florida's citrus industry with billion dollar losses. As far as we
know, and the latest news is exactly one day old, this is not a bac-
terium introduced from another country. We know the bacterium
was here. It is not even a strain introduced from another country.
As far as we know, it is a mutation that occurred in the State of
Florida. It could have happened anywhere, but it happened to have
happened there.
There are other examples in the more classic literature. A good
example is the apple maggot, which is a fly that until 1865 was
only found on hawthorn. It was never found on apple. Then sud-
denly it was reported attacking apples in the Hudson River Valley,
and then in a couple years New England, and by now, a century
later, it has spread all over the Eastern and North Central United
States.
It is a major economic pest. There is very good evidence that this
host shift from hawthorn to apple was the result of a single muta-
tion, allowing the larva, the maggots, to mature on apple, whereas
before it required hawthorn.
The rice brown planthopper is another very well studied exam-
ple. This is a bug that is a terrible pest of rice in Asia. Until re-
cently it existed in Asia where it is native but was a very minor
problem. Then in the early 1970's, there was suddenly a devastat-
ing outbreak of it in the Philippines. The bug itself began to cause
more damage and to transmit harmful viruses. Over a few years it
spread to Indonesia and then to India and now it covers much of
Asia.
There has been extensive study of this insect, and there is excel-
lent evidence that what happened was that a new gene arose, a
mutation, that made the insect much more virulent.
The southern corn leaf blight is another example dear to the
heart of many southerners. This is the fungus that devastated the
corn crop in the South in the 1970's. After having been present and
not having caused much problem, exactly why it became a pest in
1970, a major pest, we don't know, but we have very good support-
89
ing evidence that part of this was genetic change. It is known that
at exactly the same time it became an economic crisis, there was a
genetic change in the fungus that caused very different effects on
the plant.
As a final example, from vertebrates, the collared turtle dove
was restricted to the Balkans, a small part of the Balkans, until
the 1920's. Suddenly it began to spread like wildfire throughout
Europe and into Asia Minor. Now it covers all of Western Europe
and much of Asia Minor. It has been a very serious pest.
The expansion occurred in spite of tremendous hunting pressures
and other measures aimed at slowing it down. Exactly what hap-
pened we don't know. We don't have nearly as much evidence as
we have in the case of the rice brown planthopper or the apple
maggot. But Prof. Ernst Mayr of Harvard University, who studied
this case, believes that a mutation changing behavior of the bird
slightly is at the root of this.
I could give a number of other examples, but I think these
should establish that a small genetic change in native species can
lead to great ecological and economic problems.
One can also see how small genetic changes even in native spe-
cies can be very damaging by looking at how pesticide resistance
has arisen in hundreds of insect pests just over the past few dec-
ades.
Time and time again we have the situation where a chemical
controls the population for a few years, then a resistant strain of
the insect develops by a mutation, natural selection occurs, and
control is lost. So we have to find a new chemical and then the
process begins over again.
There are several insect species, including some mosquitoes, that
are resistant now to every chemical we can throw at them. The de-
velopment of resistance is a grave agricultural and public health
problem. In some instances we are even worse off now than when
we began using pesticides because the natural enemies of some of
these pests have not been able to develop resistance and they have
been locally eliminated.
The important thing to know about the development of resist-
ance is that it usually rests on a very simple genetic change; in
fact, often a single gene. This can come about in several ways. It
can be as simple as a behavior change, causing the insect to sit on
the bottom of the leaf instead of the top of the leaf so an aerial
spray doesn't reach it, or it can be a mutation that detoxifies the
pesticide so it is no longer a problem, or it can change an enzyme
that had been damaged by the pesticide so that the enzyme itself is
resistant. There are other ways in which resistance arises, but they
are all very minor genetic changes, often involving single genes.
I do not mean to leave the impression that most genetic changes
that happen in nature are bad problems. We have very good evi-
dence that most mutations are never even propagated. They render
the organism less fit and they disappear. I think this is probably
what is going to happen to most genetically engineered organisms,
in spite of the great ingenuity of the gene-splicers. But just as
every so often a natural mutation causes the species to become a
problem, it is quite possible, in fact, I think it is almost certain,
that every once in a while a genetically engineered organism will
90
become at least somewhat of a pest, especially given the nature of
the changes that are being envisioned.
I want to say a final word about introduced species. Most of them
do not become pests. I have surveyed about a thousand of them
that at least survived. Most of them don't even survive. We have
no idea how many introduced species there have been. But of the
thousand that survived, I found only about one-quarter that had
some ecological significance. For many of those it wasn't much of
an effect.
A few of them are well-known catastrophes: the Japanese beetle,
the kudzu, the starling, et cetera. The only thing I want to add
here is that some of these species and some other ones that are less
obviously devastating, in addition to the obvious effects, like defoli-
ating our ornamental plants or desecrating an orchard like a star-
ling does, have very subtle ecological effects, like affecting produc-
tion rates of trees or rates of nutrient cycling. These may be of
very great economic importance, even if they are not obvious.
Now, what does all of this evidence suggest to me we should do
about releasing genetically engineered organisms?
Since there are so many benefits that are promised by genetic
engineering, in health and in agriculture, I think it would be fool-
ish to try to stop it. In fact, I know it won't happen. There have
been many introduced species that have been very beneficial. Many
of our food plants are introduced species. So it would have been
very unwise for us to try to stop introducing all exotic species.
However, the potential dangers from releasing genetically engi-
neered organisms are probably about as great as those from natu-
ral genetic changes in native organisms or from standard conven-
tional techniques of genetic engineering that plant and animal
breeders have been using for a long time. I think they are probably
as great as those from introduced species, on average. Since we can
point to disasters in each of these areas, I think we really do have
something to worry about.
However, I think that most of the disasters that arose from intro-
duced species and probably also from naturally changed native spe-
cies could have been avoided if there had been very careful study
beforehand of the properties of the new genetic races or of the in-
troduced species. I don't mean just running off a checklist of the
properties of the proposed introduction that could be done by one
technologist working for a week or even 6 months. I mean a full-
fledged ecological study or study by a committee including ecolo-
gists and evolutionary biologists.
This would have to be done on a case-by-case basis, just as the
FDA now assesses proposed new pharmaceuticals and the EPA
mandates environmental impact statements. I think teams of spe-
cialists, including experts from the fields of ecology and evolution-
ary biology, could give very good advice and could minimize the
risks of releasing genetically engineered organisms.
As in any risk-assessment procedure, it can never be foolproof
and sooner or later an unforeseen consequence will occur. Howev-
er, I think that this risk can be greatly brought down by having
very rigorous testing procedures overseen by an appropriate panel.
I don't have expertise in organization of Government, so I don't
really feel qualified to say whether this should be done in the con-
91
text of an existing agency or group of existinq agencies or whether
something very different is needed. Of course, the FDA, EPA, the
Department of Agriculture especially, and the NIH all already
have expertise and responsibilities in rather similar situations. I
am not yet confident that they would do this right. I am not saying
they wouldn't, but I would like to see the proposed guidelines. I
know that these are already being considered.
That is my final message. I think that lessons from the ecological
literature suggest that there is definitely something to worry about
here but that we should be able to minimize the major risk.
Senator Durenberger. Thank you very much. Dr. Simberloff.
Mr. Doyle?
STATEMENT OF JACK DOYLE, DIRECTOR, AGRICULTURAL
RESOURCES PROJECT, ENVIRONMENTAL POLICY INSTITUTE
Mr. Doyle. Thank you, Mr. Chairman.
I would like to thank the subcommittee for inviting us to testify.
We appreciate the invitation. We commend the chairman and the
members of this subcommittee for initiating these important hear-
ings.
I must say that I didn't mean to intimidate the chairman or
other members of the committee who may have seen my statement.
Most of it is appendix. We hope that the full text will be entered
into the record. I will proceed and try to excerpt from my prepared
statement.
During the last 3 years at EPI I have been working on a book
about some of the changes our society, our Nation's food and farm
system, and our environment will likely experience with the appli-
cation of biotechnology and genetic engineering to agricultural pro-
duction. In the course of writing this book, which is scheduled for
publication early next year, I have visited with numerous scientists
and businessmen in the seed industry, at new biotechnology compa-
nies and established corporations. I have spoken or corresponded
with hundreds of people in what might now be called the agricul-
tural genetics business.
I My discoveries so far leave the distinct impression that there is
/ much promise with the use of new genetic technologies. However,
^ there are also some clear reasons for concern and caution.
Advances and breakthroughs in the genetic sciences have oc-
curred much faster than anyone anticipated, even as recently as 5
years ago. Huge sums of capital are being invested here and
abroad, and a race has ensued among scientists, biotechnology com-
panies, major corporations, and even national governments seeking
technological supremacy in world markets.
Now in the United States, as genetically altered products draw
nearei' to commercialization, there is great pressure to secure sw ift
i^ 'ederal approval for these pro dii<"ts Vpt, ther e has be en little
public _.debateonthe potential environmentaTl ind social~~conse-
quences oFthTsTiew tec hnologv. ~ "^ ^
With the exception oT^Ehe^sefies of hearings held by the House
Science and Technology Subcommittee on Investigations and Over-
sight, and its February 1984 report entitled "The Environmental
Implications of Genetic Engineering," there has been very little ac-
92
tivity in Congress on this subject. Policymaking on the question of
environmental release seems to be evolving more in the courts
than it is in Congress.
While we may be in a period of deregulation and Government
disengagement in some areas, it is our view that biotechnology and
genetic engineering need to be regulated and monitored by the
Federal Government.
There is every reason to be careful and cautious with the ad-
vance of this new technology and to question ironclad assurances
that genetic engineering is so exact and precise that everything is
under corttrol and there is nothing to worry about. We have heard
that once before.
Asrece ntly as 1970, plant scientists generally thought that the
genetictr^ts that determine disease resistance and /or susceptibili-
ty IrTcrops^were contained in the nucleus of t he cell. But after the
southern corn leaf blight, which Dr. iSimberToff referred to, wiped
out 15 percent of the Nation's corn crop in 1970, scientists discov-
ered otherwise. fThey discovered-that cytoplasm, the liquid material
contained in every celira i so had so mething to f\n with the genetics
orj[is ease reaction. They later learned that genetic information
contained in the cell's mitochondria accounted for the corn's vul-
nerability. That was new mformation.
Today, as in 1970, we continue to learn new things about genes
and how they act. Only in the early 1980's did we first hear the
term "promiscuous DNA," meaning that DNA sequences could
move about within the confines of the cell, in this case between
chloroplasts and mitochondria.
Scientists studying this transfer activity at Duke University and
the Carnegie Institution of Washington conclude that it is not a
rare event, but a "general phenomenon." Before this discovery, sci-
entists had assumed that intracellular organelles like chloroplasts
and mitochondria were independent of each other. Now they know
differently. But how the DNA gets from one organelle to another is
still a mystery. So there is still an awful lot we don't know about
the genetics inside of the cell.
Sometimes, however, it takes the scientific community a good
while to accept such knowledge. In 1951, to the disbelief of her sci-
entific peers, Nobel Prize winner Barbara McClintock first offered
her discovery of "jumping genes." McClintock discovered that the
genes on chromosomes, once believed to be stationary and therefore
predictable in the genetic characteristics they controlled, could
move or jump from one chromosome strand to another, thus affect-
ing changes in the expression of certain traits. It took nearly 20
years for the scientific community to finally accept McClintock's
discovery.
Today we are confronted with man-directed changes in this
inside genetic world with new products being released themselves
into the tremendous variability of the outside environment.
The available evidence here seems to indicate, as we have heard
from Dr. Alexander and now Dr. Simberloff and others, that based
on past introductions, most genetically altered organisms will not
survive, but some will, and a few will create problems.
On the one hand, we have a science of ecology that is young, not
yet predictive, in Dr. Alexander's words. On the other, we have a
93
bustling new industry ready with genetically altered microbes and
other substances to be released into the environment.
/ In our opinion, it is not a question of whether Government
should regulate, but how. To do otherwise would be to make the
Federal Government an accomplice i n an ecological crapshoot.
It is clear that a careful debate is necessary about how to regu-
late responsibly, one that covers all options and possibilities, and
one that allays public fears and instills confidence that the new ge-
netically created substances for agriculture, mining, enhanced oil
recovery, industrial bioprocessing, and other uses will indeed be
safe.
I might say that while fostering scientific and technological inno-
vation are important, and important to our country and national
leadership and international markets, so are public health and
safety here at home and environmental protection, as well.
As the regulatory debate moves forward, there are some steps
that can be taken, however. F ederal research dollars allocat ed
car efully to EPA, J LTSDA, FDAj and the land grant universities can
e ffslire that we have a predictive ecology in place before new ge-
ne ticallv altered substances are released into the environmen t. In
fact, Federal funds earmarked for biotechnological research might
"build in" a predictive or consequences requirement as a part of all
such grants, which would serve the purpose of inculcating such
forethought into the process at the same tim.e the research is being
done.
But our concerns for environmental safety and ecological impacts
go beyond establishing a sound predictive science base and a re-
sponsible regulatory framework. Our concerns also include the po-
tential secondary impacts, the indirect environmental and agricul-
tural consequences of biotechnology.
I would like to touch on a few of those, if I could.
/ At present, we are most concerned that some developments in
/biotechnology and genetic engineering might foster an increase in
/ the use of pesticides in the environment and per happ pyanprhate in
the l ong run some toxic_siihstanrps problem s, which I am sure this
' subcommittee is well acquainted with. Here, we are concerned
about the genetic alteration of agricultural crops to make them
resist herbicides.
Herbicides are chemicals designed to kill plants. However, few
crops have the natural ability to tolerate the ill effects of herbi-
cides. Some do, however. Wheat, for example, has an enzyme which
naturally detoxifies the killing action produced by du Font's new
herbicide. Glean. Corn produces an enzyme which makes it resist-
ant to the lethal effects of the herbicide atrazine. Yet, soybeans
and alfalfa, two crops that might be used in rotation with corn, are
not tolerant to atrazine. Similarly, sunflowers, sugarbeets, and len-
tils, crops that might rotate with wheat, are damaged by the herbi-
cide, Glean. Moreover, these crops can be damaged by these herbi-
cides even when the chemicals are carried over in the soil from
previous applications.
But that is where biotechnology and genetic 'engineering enter
the picture. Today scientists use tissue culture techniques in the
lab to screen thousands of cells for potential herbicide-resistant
survivors that may later be turned into new crop varieties.
39-383 O— 84-
94
For example, Monsanto's plant sciences research director, Robert
J. Kaufman, testifying before a House subcommittee in June 1982,
explained his company's work with alfalfa plants and the herbi-
cide, Roundup:
Alfalfa tissue was placed into culture first on solid media and later into liquid
culture. In liquid culture, the cells were exposed to a lethal dose of the herbicide,
Roundup, and the survivors were plated out for regeneration into whole plants.
These new plants (or variants) were transplanted into the field and treated with
Roundup the way a farmer would use the herbicide. Several variants were found to
have field resistance to the herbicide.
Monsanto, of course, is not the only company now using biotech-
nology to help design crop varieties that will resist their own or
other herbicides. In appendix A you will find a sampling of biotech-
nology companies and major corporations doing this kind of work,
ranging from Du Pont to any biotechnology companies like Molecu-
lar Garrete.
One recent biotechnology companys' prospectus, for example,
noted that some U.S. scientists working with tissue culture tech-
niques have screened and selected out plant cells to regenerate
plants with resistance to such herbicides as 2,4-D and paraquat. In
a few cases, scientists have also cloned genes for herbicide resist-
ance that might be moved into plants that don't have that resist-
ance now. Such matching of herbicides with crop varieties geneti-
cally altered to withstand them will increase the use of those sub-
stances.
Not much is known about the long-term effect of herbicides in
the environment. Although herbicides are generally not regarded
to be as toxic as the chlorinated hydrocarbon insecticides used in
the 1960's, they do have side effects. Not much is known about how
herbicides completely break down, and according to some scientists,
such information is only known for about four of the 150 herbicide
compounds presently in use.
Herbicides such as atrazine have been found to cause chromo-
some breakage and other aberrations in plants. In fact, triazines,
the chemical family to which atrazine belongs, generally are
known to be mutagenic to some insects such as fruitflies. Moreover,
recent revelations about one popular Monsanto herbicide. Lasso,
vl^ which was recently found in Ohio drinking water, have raised ques-
^ tions about herbicide safety. Nevertheless, huge R&D investments
continue to be made in herbicide chemistry, some of which is now
buoyed by the prospect of genetic engineering.
Herbicide-resistant crops are one only area in a whole new world
of agricultural chemistry that biotechnology may create. Research
directors at many of today's leading chemical and pharmaceutical
companies will tell you that they see a much more sophisticated
era of agricultural chemistry ahead, one that includes plant growth
regulators, encapsulated and synthetic seed, new kinds of microbial
pesticides, viruses and genetically enhanced bacteria. Du Pont and
Monsanto, for example, have both integrated growth regulator re-
search with their plant genetics and plant biotechnology programs.
Some commercial scientists have told me that the reason they
are pursuing herbicide resistance in crops is because it is easy, a
single-gene change in some crops and one of the early gains of ge-
netic technology. "You have to start with what is there to demon-
95
strate what can be done," one researcher told me. It is an under-
standing, he said, that will lead to other more sophisticated break-
throughs later.
Yet, herbicide-resistant crop varieties will be commercial prod-
ucts, and it is commercial products that this new industry wants
most to show its stockholders, its underwriters. Wall Street and the
media. While producing such products may be an innocent and nec-
essary step along the path of genetic science, it will also be a
highly capitalized step backed by a mass production system de-
signed to recoup a return on investment.
Our concern here is with momentum, the commercial and scien-
tific momentum that builds around any new and dynamic technolo-
gy-
Senator DuRENBERGER. Are you near the end, Mr. Doyle?
Mr. Doyle. Yes.
Our concern is that a certain kind of product momentum will be
set in motion in the earliest stages of this technology that may be
difficult to turn around should something go wrong, difficult to re-
verse because of huge capital investments, scientific careers on the
line, and accrued political support.
I would like to say a word about some of the impacts that this
technology will have. Just to mention briefly, while I know it is off
the subject a little bit, I think there will be some changes in the
agricultural system that will result from the application of this
technology. I would just like to raise a few of those examples here.
^ Just as we are now paying some attention to the potential ecolog-
/ \.Q,2i}^ consequences of genetic engineering, we must also plan for
/ s gcial and economic chang es that rnnlH romp to a griculture and
^ .ru ral Americ a with np"^ \o.nVxinr,\(\i^j
For example, a genetically engineered bovine growth hormone
enabling cows to produce 40 percent more milk on less feed could
have dramatic impacts on the dairy industry. Some estimates have
suggested that if widely used, bovine growth hormone w ould bring
a bout a reduction of the Nation's dairy herd bv one-third. T hat
would mea n a dramatic red uction in farmers and farm numbe rs. A
sfmilar development in the beet or pork industries would not only
affect cattle ranchers and hog farmers directly but also feed grain
producers nationwide. These changes, in turn, might lead to sub-
stantial changes in Federal farm policy.
To summarize, the Environmental Policy Institute finds that
there are potential benefits and opportunities to come with biotech-
nology and genetic engineering in agriculture. There are construc-
tive applications and inventions that can help to eliminate or
reduce the use of chemicals in the environment, and these should
be pursued sooner rather than later.
There should also be opportunities to diversify our agricultural
production base through the use of new kinds of crops as well as
ways to reduce the farmer's cost of production with disease-resist-
ant crops and the development of hardier crops.
However, we also believe that there is need for great caution in
the microbial realm, and that Federal regulation and funding for
predictive ecology research are essential to ensure public confi-
dence in this new industry.
96
Indirect and secondary impacts, such as those possibly resulting
from herbicide-resistant crops, need to be considered, now, before
capital investment makes their reconsideration later impossible.
Perhaps ;fvPA nppHs to plav a more direct role in f orcing the consid-
efatTorTof alternati ves to products such as herbicide-resista nt crops.
BytHis^rmeahTEere is a need for some Federal role to look at al-
ternatives in the biological area, for example. That might be one
thing that Federal review agencies should consider in their evalua-
tion of new agricultural biotechnology products.
Senator Durenberger. Are you at the conclusion? I have let you
go 6, 7 minutes beyond the time.
Mr. Doyle. I apologize. That is fine.
Senator Durenberger. Thank you.
STATEMENT OF JEREMY RIFKIN, PRESIDENT, THE FOUNDATION
ON ECONOMIC TRENDS
Mr. RiFKiN. Good morning.
I would also like to thank the committee for inviting me to testi-
fy this morning.
Senator Durenberger, I would like to take a little bit of a differ-
ent approach this morning because I think many of the issues that
I would have raised have already been adequately raised by other
witnesses. Since this is the first hearing of this type in the Senate
dealing with genetic engineering and the environment, I would like
to try and place it in a broader context, if I may, for a moment.
In 1973, that was the year of the energy crisis. Things have dra-
matically changed in terms of how the developed economies see
long-range forecasting as a result of that banner year.
I would like to suggest that we are now seeing the first stages of
a long-term transition over decades and perhaps several centuries
out of the nonrenewable industrial type energy base into the re-
newable energy base, and biology is our chief focus for organizmg
our activity. This will become increasingly more relevant as the
decades pass and biology will become increasingly more important.
The real question, I think, in front of this Congress, and it is also
a question being debated by other nations right now, is how do we
begin to approach the age of biolog>\ How do we begin to restruc-
ture our relationships with nature. What is the economic implica-
tion of the approaches that we choose to use now. Those implica-
tions might not be well advanced until 50, or 75, or 100 years from
now.
Now, I disagree with those people in the industry and the scien-
tific community who say that genetic technology is simply an ex-
tension of the type of breeding or domesticating experience that we
have availed ourselves of since late Neolithic man. In fact, it is
quite different, qualitatively different. I venture to say the only
parallel to the genetic technology that makes sense anthropologi-
cally is the harnessing of fire. For a long time human beings have
been burning, forging the Earth's crust. We have successfully been
turning it into all sorts of interesting things: steel, glass, cement,
synthetics.
In the 1970's, the biologists came up with a new tool which is
comparable in impact to fire technology, in my mind. The tool is
97
recombinant DNA. It allows you to take genetic materials from un-
related materials and recombine them, on a molecular level, that
does not exist in nature. In a metaphorical sense, we can burn,
sodder, forge, and heat, and cross all species boundaries and create
new living products that never existed in the natural state.
Let me give you an example of what you can do in genetic tech-
nology that you can't do with normal breeding. Dr. Ralph Brinster
at the University of Pennsylvania several years ago took a gene, a
human growth hormone gene, and inserted it into mice embryo.
The mice were born unlike any mice in history because they were
expressing that human gene factor. Some grew twice as fast and
twice as big. More interesting to me is the fact they passed the he-
reditary gene into their offspring so successive generations of mice
have this human gene factor expressed in a very dramatic way.
There is no breeding measure in nature that we know of that
can accomplish that fete. What I am saying is genetic technology
allows us to eliminate species boundaries, species walls, the whole
idea of the in viability, an arcane concept once we introduced re-
combinant DNA into our economic way of life. The sacred unit is
no longer the species. It is the gene. In fact, it is no longer the
gene. It is the information coded in the gene that can be synthe-
sized by computer programming.
What are the implications to the environment for this kind of
dramatic change in the way we relate to, organize and conceptual-
ize nature?
First, we have to understand that biological products that are ge-
netically engineered differ substantially from petrochemical prod-
ucts. A genetically engineered product is alive. We often forget
that. Because it is alive, it is inherently more unpredictable and
unstable in the way it might relate synergistically to its environ-
ment. They oftentimes will reproduce. They will migrate, grow.
You cannot constrain them to a given geographical locale as you
oftentimes can with a petrochemical product.
Third, a genetically modified product cannot be recalled back to
the laboratory or be placed back into a drum or sealed up if it is on
the microscopic level. Once it is introduced, that is it, and you have
to live with the consequences.
Up to now, in the last year, we have been talking about a few
experiments in the environment. But let's take it down the line 2,
3, 4, 5 years from now.
During the petrochemical age, we introduced thousands of petro-
chemical compounds into the environm^ent each year. Most of them
were benign. A small percentage of them were not. That small per-
centage has created a very difficult legacy for future generations to
deal with. You eloquently addressed that. Senator Durenberger, in
your opening remarks. It is very likely, in fact, I would say it is
assured, that we will introduce thousands of genetically modified
organisms into the environment each year, just as we did with pe-
trochemicals. Probability suggests to me when you are introducing
thousands of new genetically modified organisms into the environ-
ment, a small percentage of them are going to have possible prob-
lems associated with them. But unlike petrochemicals, the prob-
lems associated with living products could be irreversible, cata-
strophic and the legacy might not be one we can clean up.
98
Second, I think that we have to take a look at how genetically
engineered products will impact other areas. Microbes have been a
favorite topic over the last year, but let's take a look at plants.
What i am about to say is I am trying to make a broader point,
that there is a myth to this revolution as we approach it in a
animal husbandry and agriculture. The myth is if something is
alive and reproducible, it is perpetually inexhaustible. We have
had a long history with petrochemicals. They can be deleted and
exhausted, we know. Unfortunately, most people believe living
things are never run out because they reproduce. The central myth
of this technological revolution in agriculture is you can get some-
thing for nothing.
Let me give you an example of why I believe living resources are
as depletable and as exhaustible and as finite as fossil fuels. Let's
take one example from genetic technology, photosynthesis. What if
we could find a way to genetically engineer a plant so it would in-
crease photosynthesis by 1 percent, so instead of 1 percent you get
2 percent. What would be wrong with that? That is the beginning
of the food chain. It sounds terrific until you look at the conse-
quence.
In order to absorb the increased ray of photosynthesis, we are
going to have to apply more nutrients to the soil that would have
to be used and absorbed in order to be able to compensate for the
increased rate of energy flowing into that plant.
As you know. Senator, soil erosion and soil depletion is one of the
major central problems facing our agricultural policy today. I am
suggesting that if we radically increase the production, the yield of
our agricultural products with genetic technology, we will run the
risk of further depleting an already overtaxed soil base, leaving
future generations with less ability to sustain agricultural crops
than we have today.
Then, there is the crossing of species boundaries which no one
seems to like to talk about. We are going to be seeing increasingly
in animal husbandry, efforts to take genetic traits from one species
and then interjecting them into the hereditary blueprints of unre-
lated species. There are potential long-term consequences, both en-
vironmental and philosophical, to this radical change in our animal
husbandry policy.
First, on the environmental side. One could easily speculate that
in introducing genetic traits from one species into the hereditary
blueprint of another over decades and centuries that could do tre-
mendous long-term harm to that species and perhaps not until it is
too late and we see the damage done we might find the species
itself could face extinction as a result of having foreign genetic ma-
terial constantly forced into its hereditary blueprint.
Then, there is the philosophical question, which to my mind is
an important one. Do species have any kind of right or inviability
to their integrity of their gene pool? Are all animals here just as
matter for manipulation? Obviously, we have to eat. I am not sug-
gesting we reduce our diet to fruit and berries and nuts. But I am
also suggesting the rest of the plant and animal kingdom has a cer-
tain inviability to their own genetic makeup. If we begin pall-mall
introducing genetic traits into the hereditary makeup of species,
for short-term economic and social purposes, we might in a sense
99
be undermining a very basic concept of our society, which is our
long-treasured assumption there are certain sacred boundaries
when it comes to plant, animal, and human life. I think that is
something worth looking into in future hearings.
Then, there is to my mind the question of regulation. First of all,
I think it is rather disingenuous to even talk about regulation at
this point because we don't have a science developed to judge risk.
Sometimes I feel I am an "Alice in Wonderland" on this issue of
regulation. How can you judge risk in the various Government
agencies when it has been acknowledged over the past few years
we have never developed a predictive ecology methodology? We
have no science and protocol to judge risk. In the area of petro-
chemicals, we have toxicology, and we can judge the risk of various
products. When it comes to genetically modified products, there is
no predictive ecology methodology.
The National Academy of Sciences 4 months ago was trying to
gather some money to do a first study. I don't think we should go
ahead and regulate until we can be convinced at least in some min-
imum way that there is a set of protocols, a scientific methodology,
that would allow us to minimize risk.
I would suggest the best scientific talent in the country come to-
gether, not a token biologist or a token ecologist, but a cross section
of opinions at the heart of the scientific community to see if they
can't in fact come up with some kind of protocol for the develop-
ment of this technology into the marketplace. If it turns out in the
final analysis, by the way, we can't develop a science to judge risk
and that it is too problematical, then I for one would say we should
take the more prudent course of action and take the status quo
against embarking on this radical change in the way we change
nature.
Then there are international implications. To give you an exam-
ple of how little thinking has been going on in some of these Gov-
ernment agencies, without naming names in particular, we have
had several meetings on the international front now to discuss reg-
ulating this technology. In none of the meetings did they bring up
the following problem. Countries like Germany, France, and The
Netherlands are going to be introducing thousands of genetically
modified organisms into their environment each year. Those orga-
nisms are not going to respect geopolitical boundaries like chemi-
cals did. We have acid rain as a big problem now. Acid rain crosses
boundaries.
What I am suggesting to you is genetically modified products, es-
pecially when you introduce thousands and thousands over years
and decades, are going to cross all geopolitical boundaries. An orga-
nism you place in a southern France ecosystem that migrates to
The Netherlands, it is fairly displaced. What corporation will be
liable? What international body is going to deal with this?
It boggles my mind to try to imagine how we would determine
liability for thousands of genetically modified products across all
political boundaries in the coming decades. That has not even been
addressed in the first international meeting we have taken part in.
Finally, I am very concerned about some statements in advance
of this technology coming on line. I kind of feel like we are getting
steamrolled into this biotechnical revolution with very little
100
thought. We have developed a shadow self. It is called the Japanese
Nation. Whenever we have a problem here that we don't want to
deal with, we say the Japanese are coming and, therefore, we
better get moving. If it isn't the Japanese, it will probably be the
Germans.
I am interested to note that Dr. James Weingarden at the Na-
tional Institutes of Health made the following statement in Science
magazine in August: "Biotechnology is coming to fruition. We can
create a chilling effect and drive the industry abroad if we move
toward too much regulation." I thought the Director of NIH's job
was to look at research and the application of research, but I didn't
believe his job had anything to do with commerce.
Secondly, Mr. Don O'Clay, who is Deputy Assistant Administra-
tor at EPA, directing the agency's regulatory guidelines, said, "I
am looking to regulate with a light hand." My God, they haven't
even put out protocols yet. Here is an administrator of an agency
announcing to the public in advance of protocols that "I plan on
dealing with this with a light hand."
What I am suggesting is there is a feeling in this country now
that chemicals are evil and bad, and living things are good. What I
am saying is that genetically modified products are at least compa-
rable to petrochemical products with the possible long-term impact
they can have on the environment. To my mind, they are not only
comparable, but they eclipse in a magnitude to any damage we
have seen from the petrochemicals age.
We owe it to ourselves as a society, and we owe it to future gen-
erations to take a long, hard look at this radical departure and ask
the question are we wise enough and smart enough to begin the
process where we become the architects of life, the designers of a
second genesis, the creators of our own living ecosystem? I for one
have grave reservations about the whole thing.
Thank you.
Senator Durenberger. Thank you very much.
Gentlemen, Mr. Rifkin has just given us what I knew he would, a
challenge. If I might start with you. Dr. Jackson, let me ask you to
react to the comments that Mr. Rifkin has just made, I think par-
ticularly relative to the comparison with petrochemicals which he
stretched out. I think he made several comparisons in that regard.
Let me just ask you to react to his comments.
Dr. Jackson. I must say I agree with some of Mr. Rifkin's prem-
ises. I certainly agree that the economic and technological impact
of biotechnology is going to be at least on the order of magnitude of
the impact of chemical technology, and not just petrochemicals, but
chemicals in general.
Mr. Rifkin also said that when one introduces a large number of
different genetically engineered organisms into the environment,
the probability is that there will be potential problems with some
of them. I have absolutely no argument with that statement. That
statement is reasonable on its face. The real issues however, are
what fraction of the organisms will present potential problems,
how great are those problems, and how easy will it be to predict
and either avoid or control them?
What I fmd disturbing about Mr. Rifkin's characterization of the
technology as very hazardous is that by his own statement, there is
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a vast majority of introductions of genetically engineered orga-
nisms which will not have potential problems associated with
them. Since no one is doing these introductions just for the fun of
it, one assumes this vast majority are going to have potential bene-
fits associated with them. Are we to throw out a healthy, vigorous-
ly growing baby to get rid of a drop of bath water?
I think what we have to do is to be cautious in our introduction
of these organisms into the environment. As several witnesses in
these hearings have urged, we must support more research in ecol-
ogy and environmental studies so we have a better knowledge base
to predict when we are facing potential problems, and we have to
proceed on that basis.
One of the points that I made is that the notion of a technology
which poses zero risk to society is a will-o'-the-wisp. Pursuit of that
will-o'-the-wisp is a prescription for paralysis. What we have to do
is to seek for progress in ways such that we adequately protect our-
selves while moving forward. I think we can do that in this area. I
think we can and to a large extent have done that in the area of
chemicals as well. We must not let the undoubted fact of some po-
tential problems make us lose sight of the fact that there are also
enormous potential benefits.
I have a little more problem reacting to Mr. Rifkin's comments
about the problems of crossing genetic boundaries and integrity of
gene pools and inviolability of species because I am not really sure
exactly what he is suggesting.
If, for instance, he is suggesting, as he seemed to, that the intro-
duction of genes on a consistent basis into a particular species of
plant or animal was somehow going to unalterably modify that spe-
cies in the environment and change it out of recognition, all I can
say is that unless there is an extraordinarily strong natural selec-
tion in favor of the altered organism, what he seems to be suggest-
ing simply won't happen naturally. It is impractical to go around
and introduce the genes for some change into every corn plant or
every field mouse in the world. That is so absurd I can't think that
is what he is seriously suggesting.
I think it is also important in terms of Mr. Rifkin's references to
the inviolability of gene pools and the sacred units of genetics to
point out that one of the things that we now know is that the gene
pool of organisms and species is not fixed but is in fact extremely
plastic. We know this as a consequence of having done a great deal
of basic research in molecular genetics over the course of the last
10 years. Genes and genomes which vary are found both in higher
organisms, such as animals and plants, and also in lower orga-
nisms, such as bacteria and fungi.
Mr. Rifkin cited Dr. Barbara McClintock's work with corn, which
was in fact one of the first instances where the plasticity of an or-
ganism's genes was demonstrated. We now know that such changes
in genes and their organization in chromosomes is in fact a normal
part of the developmental process of many organisms. In man,
major and substantive genetic reorganizations do occur in some of
the most important cellular systems in the body. For instance, in
the immune system in man, such reorganizations occur as a
normal part of development.
102
So to suggest that there is somehow an invariant gene pool
which is engraved on a molecular scale on marble tablets and
which is the unchanging genetic definition of corn or mice is
simply not in accord with the facts as they have been established
over the course of the last decade.
I would like to make one other comment at this point, and that
actually refers to something that Mr. Doyle said. He said that
people have given ironclad assurances that genetic engineering is
so exact and precise that everything is under control and that we
are able to predict all its consequences. I would like to make it
clear that I do not share this view as stated and that I believe that,
if such statements have been made, they are inappropriate. I think
that no scientist should be giving those kinds of ironclad assur-
ances that genetic engineering or any biological technique is such
that we understand all the secondary and tertiary consequences of
changes in organisms, particularly when we are talking about
something as complex as interactions with the environment.
Now, with respect, I have not heard very many people stating
what Mr. Doyle said they were. Rather, I think the argument has
been that in a few specific cases we know enough about these sec-
ondary and tertiary consequences to permit careful experimenta-
tion regarding the ecological consequences of introduction of some
organisms.
At this juncture, I want to reemphasize something I said in my
testimony. If we don't do those kinds of experiments, if we don't try
to get more facts, we will maintain ourselves in the state of igno-
rance we are today, which we all agree is not acceptable.
Senator Durenberger. Dr. Simberloff?
Dr. Simberloff. First, just as a fast response to Dr. Jackson. If
you would like to see a claim of exactly the sort that Dr. Doyle said
is afoot in the community, you might look at the letter by Bernard
Davis, who is an endowed professor of bacteriology at Harvard
Medical School in Genetic Engineering News in July and August,
and also in Discover magazine, saying exactly that there is virtual-
ly no problem whatsoever.
In response to Mr. Rifkin, first of all, I am not a theologian or
moralist so the questions about our rights of transgression of spe-
cies gene pools I really can't address. But I think that on practical
grounds Mr. Rifkin is correct, that it is not really fair to say that
the sorts of engineering that are being done now and that are envi-
sioned are really just part of the continuum of the sorts of things
that plant breeders have done for hundreds of years. The aspect of
transplanting genes, moving genes from one species to another,
really is very different.
We have been able to hybridize species by conventional means,
but they are almost always within the same genus. We could never
envision moving a gene from a human to a mouse, which we have
already done.
It is also true that occasionally hybrids of even closely related
species in nature turn out to be real pests. A very good example is
the radish of commerce, which is Raphanus sativus. That is associ-
ated with a wild native species, and the hybrid of this is now a pest
in many parts of the United States. There are other examples of
this sort I could give.
103
I think it might be very reasonable to expect that moving genetic
material between more disparate, more evolutionarily disparate
species could lead to very great problems.
A second aspect of the difference in the methods that are now in
use is one that I do not really have expertise in. But I should men-
tion that the specific way in which genes often are transplanted is
by using plasmids, which are elements that as McClintock and
others have shown move on their own, in addition to our moving
them or putting them in a position in which they can be moved. So
that it seems to me quite likely that once the genes are in place as
planned, there may be a higher mutation or movement rate. This
is something we haven't even thought about.
A final point is that the same technology that allows us to con-
sider some of these remarkable experiments could probably also be
put in the service of making them safer. As one example, microbes.
We could put in leashes, genetic leashes, and we could dictate that
in addition to whatever genes we want for other reasons, we would
demand susceptibility to a particular chemical or to a particular
virus, so that if something did get out of hand we could call it back
because the strain we released was susceptible.
As Dr. Doyle said in a different context, we could, so to speak,
ecologically disarm a new plant strain by insisting that it also be
susceptible to an herbicide that we could later use in spite of our
best field tests if something untoward happened. So I believe there
is also reason for optimism.
However, all of these things will cost money. I don't think that
the industry will be interested in doing them unless it really is
forced to do them.
I have to respond to the contention of both Dr. Doyle and Mr.
Rifkin that ecology is young and not predictive. Ecology is a young
science. The first American textbook of ecology was only in the
year 1900. So it is certainly younger than organic chemistry or
physics.
But there have been very dramatic advances made, especially in
the last 30 years. There is a large corpus of knowledge that we can
draw on. I do not believe it is fair to say that it is not predictive. It
is true we cannot in this instance provide you with a checklist so
that we can say OK, the following five criteria have been satisfied,
this introduced organism will not cause a problem. However, one
has to remember that ecologists are normally dealing with budgets
of a few tens of thousands of dollars and people call us up and say
hey, what is going to happen if I release this fly, for example. I get
phone calls of this sort.
Now, if I had sufficient resources even to fund one or two Ph.D.
dissertations, for 2 or 3 years, to deal with exactcly that topic, I be-
lieve that 95 to 99 percent of the time I could provide a valid
answer. I could be predictive. It would take a very close ecological
study of the biology of the organism and it would cost perhaps Sev-
eral tens or maybe hundreds of thousands of dollars if we were
dealing with a very large problem. The FDA, I believe, requires
tests costing a few million dollars for a new pharmaceutical.
I believe that ecology generally has been hamstrung by the
demand for quick answers to problems that are much more compli-
104
cated than the problems that physiologists routinely face. I think
that given the appropriate resources, we could be predictive.
However, I must also concede that, as for any science, no matter
how mature, like physics, risk assessment will never produce abso-
lute certainty. There will always be some possibilities of a mistake.
The best we couid ever hope to do in any circumstance is to mini-
mize that possibility. I think that with the right commitment, ecol-
ogy could lower that probability to an acceptable level.
Senator Durenberger. I think the latter is an interesting point
that I hadn't thought about in the 20 years or so that I have been
associated with environmental sciences or ecology. I would suspect
that the pressure on the science in the recent 20 or 30 years has
been so great in a political sense that without totally adequate fi-
nancial and maybe, in some cases, professional resources, the
answer usually errs on the side of finding a problem because that
satisfies the political pressures rather than on saying with a little
more study we might come out with a different answer.
Mr. Doyle, do you have a collection of responses there?
Mr. Doyle. Yes, thank you.
I would first like to correct the record. Dr. Simberloff s generous
elevation of me to a doctor is appreciated, but it is not true, in fact.
But I would say, as to my reference of ecology as a young science,
I meant to emphasize that the science of ecology is going to have to
be rewritten anew because of the genetic element now; that the sci-
ence of ecology is relatively young compared to some other scienc-
es, but now it is changing very dramatically because of the genetic
component. Certainly microbial ecology. I think in those areas
there is some concern for learning new things in terms of the ge-
netic variable.
After hearing Dr. Simberloff s remarks, I think that I should
have said that the ecology is economically deprived rather than a
young science.
With regard to Jeremy's remarks, I think something he touched
on is very important. .When he talked about photosynthesis and
looking at the kinds of system requirements and how very small
changes in a process or a cycle such as photosynthesis has to be
looked at in detail, and all of the various impacts associated with
increasing it or making a very small change in a process like pho-
tosynthesis.
I think similarly, we have to take very great care when we look
at what is happening in the nitrogen cycle, or the carbon cycle for
example. We have to have that kind of perspective as we approach
the environment with new genetic ingredients that come in at one
point or another.
One thing I aid not get a chance to touch on in my statement,
but I think it relates very strongly to the ability to regulate, and
the kinds of checks and balances we have in science for evaluative
purposes, I think today we are finding that there is a great scram-
ble for talent in a few key areas, molecular biology particularly.
We are finding that land grant universities throughout the country
are being besieged by offers. Talented people are leaving the uni-
versities for jobs in industry. Let me mention one example that I
think will illustrate how this affects agriculture.
105
A few weeks ago, I was visiting over the phone with a person in
the seed industry from Oklahoma. Oklahoma is a State that has
maybe 12 or 15 seed companies, none of which have their own
plant breeding programs. They all rely on Oklahoma State Univer-
sity for their breeding lines. Wheat, for example, is a very impor-
tant crop in Oklahoma.
This person from one of the seed companies in Oklahoma said
that recently that Rohn & Haas, a Philadelphia pharmaceutical
company that is very much engaged in developing a chemical hy-
bridization technique for wheat, carne to Oklahoma State Universi-
ty, hired away their top wheat breeder, and that has had an impact
on the seed companies, and will eventually have an impact on the
wheat lines coming out of Oklahoma State University.
Now that is just one example, but it is happening all over the
country, and not only in the plant breeding sphere, but in other
areas as well.
We have been a country, I believe, that has had in its land grant
system — and private universities as well — a capacity of our scien-
tists to play an important role in evaluating new kinds of products.
I think the ability to do that kind of evaluation is being dramati-
cally altered by this new industry, coupled with reductions in Fed-
eral funding to some of those areas of research. So I think that this
is a very important area for concern, and one I would hope this
committee would look into in the future.
Senator Durenberger. A couple of you have referred to, and I
think some of this came out on Tuesday, the pressure of innovation
and getting to the marketplace and so forth.
I understand that OTA, in a study they recently completed, sug-
gested the importance of our being out in front in this area.
I wonder if, as briefly as possible, either each of you or whoever
feels qualified to respond, and I probably should have asked this
question of Tuesday's panel also, could respond to what are the eco-
nomic pressures out there that make this new genetic engineering
industry such a great thing to invest in?
I listened to the agricultural discussion and I saw the representa-
tive from USDA do the predictable thing— give us an illustration of
productivity. Well, that is their business, productivity, however you
might define it. They do a lousy job of assessing the cost of produc-
tivity, at least as I have noticed it in the last few years here, in
terms of pesticides and soil erosion and a whole lot of other things.
But getting more seed and more kernels to the cob and more plants
per acre and so forth is what the U.S. Department of Agriculture is
all about. I can't understand why the economic pressures are to in-
crease productivity in agriculture.
From these hearings, because I haven't asked the questions, I
don't have a very well-defined sense of where the economic poten-
tial is for all of this product that we are talking about.
We will start with Jeremy.
Mr. RiFKiN. If E.F. Hutton is to be listened to on this score, sev-
eral years ago I believe it was Nelson Schneider, but I might be
wrong, who said the biotechnical revolution will impact over 70
percent of the gross national product by early in the 21st century.
We are talking here about a technology that can cruise the entire
economic span, not just animal husbandry or pharmaceuticals but
106
packing materials, building materials. There is literally nothing
that would be outside of the purview of using genetic technology.
The pressures are enormous, even though the contradictions are
apparent. I think you alluded to some of them.
For example, we pay farmers now not to produce. Now that ge-
netic technology specialists are going to develop even faster more
productive yields, we will pay farmers even more not to produce.
The same is true in animal husbandry where in so much of the
field there is overproduction right now. Without going into the
other fields, I would like to touch on one aspect of this that has not
gotten any attention. I think it is safe to conjecture that the new
form of international imperialism in the 21st century will not be
oil, it will be germ plasm.
Right now multinational corporations are prospecting the far
ends of the Earth to find wild strains and to try and locate control
and manage germ plasm of the planet. This is going to be the gold,
the oil of the 21st century.
I think the Third World nations as well as developed nations are
going to be in a mad struggle, a very, very desperate struggle on
the question of who should control genetic strains, et cetera. I
think this is something I would like to see some hearings on some-
time in the future because this will affect our national security in-
terests, it will affect foreign policy relations, and it will affect our
military objectives.
Senator Durenberger. Dr. Jackson?
Dr. Jackson. Since I was a member of the OTA panel that put
that report together, let me try to respond to the comments about
it.
I think the basic reasons for the economic pressures — I think
perhaps incentives might be a better word— to invest in biotechnol-
ogy is that it really does have extraordinarily broad potential appli-
cability. Let me just give you what I think is an historical parallel.
Back a little over a 100 years ago a group of German scientists
working in German universities laid the basis in the science of
chemistry for synthetic organic chemistry. In doing so, they really
transformed the science of chemistry from a descriptive science,
which simply analyzed the world and described what it was made
of in chemical terms, to one in which the technology was now
present to allow one to change that world, to synthesize new com-
pounds.
Out of that dawn of the synthetic age of organic chemistry came
a German chemical industry which dominated the world for the
next 50 years and which would probably have continued to do so if
it had not been for the intervention of the First and Second World
Wars.
There has been a lot of hyperbole about the prospects of biotech-
nology and genetic engineering, which is only part of biotechnol-
ogy. But I really do believe that we are at an equivalent point with
respect to biology. We are at the dawn of the syntehtic age in biol-
ogy. That is what the techniques of recombinant DNA methodology
and all the things that come along after it have really made possi-
ble. We are at a very rudimentary stage at this point, but the pros-
pects for the future in economic terms are very much the same, in
107
terms of transformation of a whole field, as they were 120 years
ago for the German chemists.
Now, what kinds of generic things can this technology do? Well, I
would argue that you can think of it really quite simply. The tech-
nology will in many different fields, ranging from agriculture to
pharmaceuticals to chemicals to energy, offer both product im-
provements and process improvements. Examples of product im-
provements might be some of the things that are coming on the
market right now in the pharmaceutical industry, where by using
genetic engineering techniques we can isolate and produce sub-
stances that you just could not get any other way. They are just too
scarce in their natural state.
So there will be all sorts of novel products that come out of this
technology, simply because these techniques enable us to access the
entire gene pool of the biosphere. It is important to understand
that the techniques of genetic engineering are very general tech-
niques. DNA is the basic hereditary substance in every living orga-
nism. If you can get the DNA, these techniques are such that they
treat DNA as a chemical, so you can isolate genes for any protein
in nature from any organism in nature. So you will have access to
a much broader range of potential gene products: enzymes, pro-
teins, hormones, and so on.
But the other kinds of generic improvements offered by biotech-
nology are in some respects perhaps even more important. These
are process improvements. They are things that affect the produc-
tivity of industries. That I think is an equally important economic
incentive as to why it is people are so interested in biotechnology.
The kinds of things I am talking about here I think will show up
first in the specialty chemical and food processing industries. An
example would be the use of products and processes developed
through biotechnology to increase the yield of a given product from
a certain amount of feedstock. There is a clear economic advantage
to the company that can do that. Another example would be is
something which will enable the rate at which you can transform a
given feedstock into a given product to be increased. That class of
generic improvement has beneficial economic consequences for the
capital investment in equipment required to produce a given
amount of product, and hence a direct impact on productivity.
Other techniques will enable one to use different and cheaper feed-
stocks to transform into a broad range of products. That too has
obvious beneficial economic consequences.
To summarize: Biotechnology offers product improvements and
process improvements which focus toward increased productivity.
It is these broadly applicable, generic improvements that are the
economic incentives in a very broad range of industries, and this is
why so much money has been invested in this technology.
Senator Durenberger. I have to ask a series of other questions
before we finish here.
First, Dr. Simberloff In the Tuesday hearing one of the wit-
nesses said that genetically engineered organisms will not be a
problem because any added genes will be well characterized and we
will know what specific traits, such as disease resistance, are being
built into the receiving organism. I think Dr. Jackson made a simi-
lar point when he pointed out these organisms are likely to be
108
highly specialized and, therefore, even less likely to survive and
multiply outside the specific environment.
I would like your reaction to those comments. Are these orga-
nisms less likely to present problems than the organisms in the ex-
amples that you gave us in your testimony?
Dr. SiMBERLOFF. I suppose a guess would be on average, yes, but
maybe not as much as one would hope. It is true that the genes
will be characterized. That will be an enormous advantage. Howev-
er, I could point out that even in pesticide resistance, for example,
many of the genes that have made the insects resistant have now
been characterized and located. The insects are still a problem be-
cause they are resistant to the pesticide. I could give similar exam-
ples of weeds.
I think that on average the danger will be less. However, since
many of the contemplated changes involve releasing an organism
from some sort of previous control, the immediate consequence
might not seem to be of economic or ecological, major ecological
significance, but there may well be concatenated effects and subtle
effects that only a very thorough ecological study could have pre-
dicted. There are many examples of this sort of thing in the litera-
ture.
So, I can't be cheered greatly by the fact we will understand the
genetics of the situation better than we have for introduced orga-
nisms.
Senator Durenberger. Let me ask each of you if you are willing
to address the subject, and do this probably in writing, to elaborate
on the hearing record, for additional research to develop some kind
of a predictive ecology. This subcommittee does have jurisdiction
over EPA's research and development authorization. We have
looked in this context into what everybody else is doing in the re-
search area. If you could help us with your recommendations about
what particular kinds of research needs to be done, what is already
being done, and where it might best be stimulated, that would be
an important part of our record, to the degree you are willing to do
that.
My next question is of Dr. Jackson and Dr. Simberloff. On Tues-
day Dr. MacLachlan of Du Pont called for regulatory review of in-
tentional release experiments. Dr. Alexander of Cornell said some
testing could be required in order to determine ability to survive
and multiply. However, Dr. Alexander cautioned that predictive ec-
ological testing is not at all exact.
I wonder if each of you would comment on the state of the art of
this kind of testing and the wisdom of requiring testing. Is there
any way to predict what will happen to an organism in the envi-
ronment without actually releasing it to see what happens?
Dr. Simberloff. I believe that field, as opposed to laboratory test-
ing for macroorganisms, plants and animals, would in many cases
allow us to be very predictive. Now, because we are talking about a
controlled field situation, in other words half an acre or an acre,
rather than a laborato/y, and we have to have stringent controls,
this sort of work is not cheap. However, there is lots of precedent
for field experimentation in ecology. Much of it is very ingenuous.
There are already some protocols — for example, caging of plants —
that have been very well established.
109
As I said earlier, given the appropriate commitment of resources,
I believe that an acceptable level of prediction could be achieved
and that this would probably be the approach that would usually
be used, field experimentation.
Senator Durenberger. Dr. Jackson?
Dr. Jackson. Since I am not an ecologist, but rather am a molec-
ular geneticist, I have to defer to my ecologically trained col-
leagues. What Dr. Simberloff says seems to make a great deal of
sense to me.
I, again just want to make the fundamental point that until one
does field testing, and I think this is what Dr. Simberloff has said
in other words, until one does field testing, one is really not going
to have a good model system to be able to get the predictive capa-
bility you would like to have.
Dr. Simberloff. However, by field test I mean a controlled field
test, before release. It is possible to control many organisms in very
large field settings. It takes ingenuity and economic support. But
this sort of thing has been done and could be done much more.
Dr. Jackson. Yes, I certainly agree it should be a controlled field
test.
Senator Durenberger. Dr. Jackson, you make the point it is the
genetic makeup of the organism that matters, not the way in
which the organism was developed. If we do decide that some form
of regulatory review is needed, and we do not predicate the review
on genetic engineering per se, how do you suggest we identify the
few organisms that might require controls from the vast number of
organisms that are developed each year? What is your handle, if
you will, on this problem?
Dr. Jackson. I think that is a very good question, and to answer
it I want to take issue with some things that have been said before
this morning.
I think it is essential to understand that genetic engineering is
part of a continuum. That is not to say that there is not a previous-
ly inaccessible extreme end to the continuum which is different
from what has been possible before. That is certainly true. And we
have heard some examples of that this morning.
But it really is part of a continuum of ways of accomplishing
changes in the genetic structure of organisms that ranges all the
way from simply going out in the environment and looking for nat-
urally occurring mutations and selecting those, all the way up
through conventional breeding programs to the induced mutagene-
sis and selection programs which have been so effective in the
pharmaceutical industry, and then finally to genetic engineering.
If you accept the assertion that it is a continuum, then I think a
reasonable way to focus one's risk evaluation efforts is to ask
where on the continuum is a particular organism or product that
one is concerned with? Is it something like a bacterium which pro-
duces an enzyme that is already a product of commerce at a higher
yield, and it does so because it is a genetically engineered organism
and it is now more efficient at producing that particular enzyme,
or is it a mouse that has human DNA in it and has some very un-
usual physiological properties that have not been seen before?
It seems to me that your first focus on your evaluation is to ask
is this something that looks like something we know about, that we
39-383 O— 84-
no
have seen before? If it is, then there are probably in fact evaluative
protocols that are already available that one can bring to bear on
it.
I think one can in general — not always, but in general — feel rela-
tively confident that you have the basic understanding that is re-
quired to evaluate such products or organisms.
If, on the other hand, the product or the organism is way out at
the end of this continuum, it is something we haven't seen before,
then it is in those circumstances that I believe a much more cau-
tious approach is called for. In these cases, one wants to give those
kinds of organisms greater scrutiny, to think through the potential
problems more carefully.
I think above all, as a matter of public policy, what we ought to
do is try to identify, with the help of the ecological community,
what are the generic problems that are likely to occur, to the
extent that there are generic problems in release of rather novel
organisms, and then get some research started on these. We need
to identify and design the kinds of fundamental experiments that
were done so successfully in the context of the biohazard debate 7
or 8 years ago to get at some generic concerns, to try to identify
what those experiments are and get on with them, so we do not
have to analyze every organism that is out on the far end of the
continuum on a case-by-case basis. We can expect to be able to
define classes in designing these experiments and to gather data on
those classes so we will be able to make decisions efficiently.
Mr. RiFKiN. I have to interject a disagreement, a very deep dis-
agreement, as to what has just been said about continuum, looking
at it in a regulatory fashion as if it is a continuum. Let me cite two
examples to show the problems.
Back in 1980, General Electric went to the Supreme Court be-
cause they developed a micro-organism that eats up oilspills and
they wanted to patent it. The problem with the Supreme Court was
that we had not had any past experience under patent laws for pat-
enting living things. The patent laws were not designed to include
living things.
My organization provided an amicus curiae along with the Solici-
tor General's case. If you take a look at the proceedings and the
battle between the amicuses and Justice Burger's decision, you see
the beginning of a precedent for redefining the meaning ^of life
which has long-term regulatory implications.
In order to squeeze living things into old patent laws, industry
and many of the amicus briefs suggested that there is very little
distinction between life and nonlife at the periphery, and further
went on to say that living things are made out of two types of proc-
esses: physiochemical and vitalistic. Vitalistic is just a term we use
before we have learned the physiochemical properties.
They said since all living things are made of chemicals and all
chemicals in combination are patentable, therefore a living thing is
patentable. I suggested at that time it is a new form of reduction-
ism, by setting a long-term precedent by suggesting living things
can be reduced to the chemical components that make them up.
Now, 4 years later, we see another problem popping up at EPA.
EPA is attempting to assert jurisdiction over biotechnology prod-
ucts under TSCA. TSCA was designed for chemicals. So now EPA
Ill
is saying its statutory authority covers living things and living
things can be for statutory purposes defined as chemicals.
Senator Durenberger, in the long run if we try and squeeze the
biotechnical age into petrochemical systems, we are going to have
problems in court systems, patent laws, in regulatory agencies, that
are absolutely unparalleled, especially when we move to mammals
and human beings, genetic engineering, genetic introductions and
alterations and reductions.
What I am seeing is how a regulatory procedure very, very force-
fully, if not subtly, begins to redefine our concept of life. What I
am afraid of is the philosophical and social implications down the
line when our children and their children grow up in a legal code
which has reduced living things to the chemical properties that
make them up. If that indeed comes about, the implications move
well beyond the regulatory boundaries and move into the whole
fabric of our social life.
Senator Durenberger. On that subject, and then I will ask you
to respond also, Mr. Doyle, I would be curious to know what any of
you know about how the insurance industry is reacting to genetic
engineering, especially to the deliberate release of organisms.
Mr. Doyle. I can't speak to the question of insurance right now,
but I did want to respond to Dr. Jackson's remarks.
Senator Durenberger. Fine.
Mr. RiFKiN. I can speak very briefly about it. Getting back to the
patenting of the micro-organism, I was curious after the Supreme
Court decision on micro-organisms why General Electric didn't go
ahead and use the micro-organism. On several occasions, one in
particular, I asked Dr. Jack Abardy, who was the creator of this
new form of life, why they had not used the micro-organism. I
never did get a satisfactory answer.
Can I tell you what my speculation is without being able to
ground it on any specific evidence? I don't think there was an in-
surance company in the country that would insure that micro-orga-
nism. I don't believe there was an insurance company anjrwhere in
the world that wanted to take the risk of putting its insurance li-
ability onto introducing that micro-organism into the environment.
That is speculation on my part, but from what I have heard over
the years, there might be some basis for it.
Dr. Jackson. I can also respond to the question on insurance, if
you would like. Genex and other new biotechnology companies in
the industry, so far as I am aware, have had no problem in getting
liability insurance. We have normal policies and normal rates.
Mr. Doyle. Senator, I would like to respond. I think one of the
thinqs that we are missing in this debate — I mean we hear an
awful lot about this continuum of genetic technology from neolithic
man up to the present day; that we have been massaging the gen-
omes of crops for a long time, and that now with genetic engineer-
ing, there is no difference. But I think there is a very fundamental
difference.
I think one of the differences is that we are doing this with our
eyes open now. We can actually see the DNA and see the genes;
and coupling that ability with other modern technology — such as
the computer in the laboratory, which is going on today in ad-
vanced laboratories throughout the country — is an awesome power.
112
You are finding, for example, the ability to match genetic struc-
tures with chemical structures, as in herbicide resistance. And
there is a whole new line of plant growth, regulators — new prod-
ucts coming out in that area.
My concern is that with this speed, you take an agency like
EPA — assuming EPA gets a jurisdictional slice of this area — new
products will be coming in, thousands of them, to the agency for
reviev/. With the new speed and capability of producing new prod-
ucts in such volume with this new technology, I wonder whether
our agencies are going to be able to keep up with doing the toxicity
evaluations that have to be done. I think it is clear, and I am sure
this subcommittee knows, that the National Academy of Sciences
just recently noted the fact that even with existing pesticides, we
don't have adequate toxicity data for 66 percent of what is in use
now. I think this technology — genetic engineering and biotechnol-
ogy — does present us with a volume problem for some agencies like
EPA, and the ability to evaluate.
Senator Durenberger. Dr. Jackson, you have the last word.
Dr. Jackson. I would like to agree with Mr. Doyle. I think there
is a volume problem here. The question is what do we do about it?
Do we give the agencies, either the existing ones or some new one,
the capability to deal with the volume problem or do we throw up
our hands and say no, we can't do it, we are going to slow down or
stop the progress? That I think is really the choice that we face.
To me, the sensible answer is to try to deal with the problems as
the work is developing because there are so many benefits associat-
ed with it.
Senator Durenberger. That is the dilemma we have been deal-
ing with in the subcommittee for 2 years and haven't found an
answer.
Mr. Doyle. I wanted to say one last thing. I think that funding is
certainly necessary to be able to do toxicity evaluation and testing.
But there are also some other kinds of approaches that can be
taken. Take USD A, for example. We believe there are benign and
very beneficial applications of this technology in the agricultural
area. If USD A were to be given a mandate that said channel your
biotechnological research dollars into finding out how you can
lower the cost of production for farmers and protect the environ-
ment, we feel there may be a coupling there. But that kind of a
mandate has to come from Congress. To direct biotechnology re-
search in that kind of fashion would be, in our opinion, a very con-
structive thing to do with this technology.
Senator Durenberger. It would be extraordinary to have that
kind of message come from Congress.
Thank you very much for your testimony. We may submit other
questions to you in writing. We appreciate very much your willing-
ness to testify on this subject. We will call on you again. Thank
you.
[Whereupon, at 12 noon, the subcommittee was recessed, to re-
convene subiect to the call of the Chair.l
[Statements submitted for the record follow:]
113
Testimony of
Thomas 0. McGarity
Professor of Law
University of Texas at Austin
Hearings on
The Intentional Release of Genetically
Engineered Organisms
Subcommittee on Toxic Substances and Environmental Oversight
Committee on Environment and Public Work.s
United States Senate
September 27 , 1984
114
Genetic engineering has emerged from the laboratory and entered the
market. As the debate over the risks and benefits of laboratory research on
new genetic engineering technologies came to an uneasy conclusion in the
late 1970s, private firms rapidly began to translate the knowledge gained in
the laboratories into commercially useful applications.
The very first commercial applications of recombinant DNA research have
used genetically engineered micro-organisms in fermentation technologies to
make useful pharmaceutical products. Similar commercial fermentation
technologies may soon yield a whole host of other commercially useful
products. While fermentation technologies raise some legitimate public
health concerns, especially with respect to workers in fermentation plants,
these concerns can be alleviated to a considerable extent through the same
vehicles that reduced concerns over laboratory research -- physical and
biological containment. Fermenters can be designed to be virtually
leak-proof, and the organisms that are used in fermentation technologies can
be engineered so that they cannot survive other than in special environments
that do not exist in the natural environment. In addition, fermentation
technologies can be closely supervised to ensure that the genetically
engineered micro-organisms that produce commercialy useful products are
killed when their job is done. By exercising relatively simple precautions,
companies can ensure that the risks posed by fermentation technologies that
use well-characterized recombinant DNA will not be appreciably greater than
the risks of older fermentation technologies that do not use genetically
engineered micro-organisms.
Genetically engineered micro-organisms can also be commercially useful
in ways that require that they be introduced on a large-scale basis into the
natural environment. I shall refer to these uses as "loarge-scale release
biotechnologies."
115
For centuries, mining companies have used micro-organisms to leach
valuable metals from low-grade ores. More recently, it has been suggested
that genetically engineered micro-organisms could be useful in pollution
control and tertiary oil recovery. Since the genetically engineered
micro-organisms in these technologies must enter the environment in very
large quantities, however, these micro-organisms are much harder to control
than those used in fermentation technologies. Physical containment is
generally impossible. Monitoring for the presence of the bugs in the
environment is very difficult, and detecting any subtle effects on humans
and the environment could be virtually impossible. Moreover, biological
containment is not very useful as a protective device, because the usefulnes
of the large-scale release technology depends upon the organisms surviving
in the environment in which they are released.
Perhaps the most disturbing aspect of large scale release
biotechnologies is the fact that the micro-organisms will proliforate, as
soon as they have found a suitable niche. For example, if the recently
reported genetically engineered micro-organism that may inhibit the natural
frost formation process does in fact have a selective advantage over its
natural cousin, then it could in time replace the cousin everywhere in the
world. If at some later point in time we discover some unanticipated
detrimental impacts of the technology, it may not be possible to call it
back, like we recall defective automobiles.
Finally, before we decide to employ large-scale release biotechnologies,
we should carefully examine the possibility that a use of the technology
that is beneficial to one person or group may be detrimental to another
person or group. Our experience with weather modification technologies
suggests that the benefits of a technology can also be its detriments. For
116
example, rain may be a boon for farmers but a bane for golfers. When the
benefits of a technology are also costs, we need to examine that technology
carefully to ensure that the benefits on the whole outweigh the costs. In
addition, we might think about reducing the negative impact of a
cost-beneficial technology by providing some sort of compensation mechanisms
through which the "winners" can make the "losers" whole. Traditionally,
state tort law has provided this mechanism, but it is always useful to
consider the capacity for the common law to deal with freshly emerging
technologies .
All of the foregoing considerations suggest that it would not be wise to
leap into a rapid commercial implementation of large-scale release
biotechnologies before we are confident that a legal and regulatory regime
is in place that can adequately address any unanticipated detrimental
effects of those technologies.
Nuclear power was once a bright new technology that offered great
promise for the future. Heavily promoted by the federal government, that
technology developed at a rapid pace, until the public assessed and debated
its full socio-economic effects. In my opinion, a large part of the
extremely negative reaction of some to nuclear power in recent years stems
from the "go-go" spirit with which, during its early developmental phase, it
was promoted with little or no regard to its downside risks. When the
nuclear power debate blossomed anew in the late 1970s, the opponents of that
technology drew upon both the deep sense of public betrayal- which
accompanied the Three Mile Island accident and the revelation that experts
were consistently overly optimistic. A similar fate could await the newly
emerging biotechnologies a decde from now if the health and environmental
risks of those technologies are not soberly assessed, publicized and
addressed in an adequate regulatory framework.
117
I. ELEMENTS OF AN ADEQUATE REGULATORY REGIME
While the current predictions concerning the hazards of newly emerging
genetic technologies are admittedly quite speculative, caution suggests that
we examine existing regultory mechanisms to see what regulatory responses
might be available should our current risk estimates prove erroneous.
Throughout this exercise, however, we should be sensitive to the needs of a
growing and potentially beneficial technolgy to be free of unnecessary
regulatory constraints.
A. Data Collecting and Monitoring
Perhaps the most important and least intrusive component of any
mechanism for regulating human conduct is collecting information on the need
for regulation. This data-gathering function is a continuous one, beginning
at the time the technology is being developed and continuing throughout its
application. At the very least a data-gathering mechanism should be capable
of compiling a central registry of hosts, vectors, industrially useful
genetic sequences, and products and by-products. A risk, assessor will also
need information on the extent to which humans and other important
environmental entities are likely to come into contact with genetically
engineered micro-organisms.
Ideally, companies would thoroughly test organisms with the potential
for large-scale application in the laboratory and in limited natural
settings before releasing them in large quantities into the environment.
Even adequate testing, however, will not prevent the organisms from picking
up a harmful trait in the environment or from manifesting an unforeseen
trait once they find an ecological niche.
The data-gathering mechanism should also be able to monitor the actual
application of biotechnologies in order to detect the improper presence of
118
micro-organisms. Monitoring large-scale relese technologies will be
especially difficult, because in many instances there will be no
geographical "places" where the organism should and should not be. The
monitoring task, will devolve to looking for the micro-organism in unexpected
niches, such as the human gut. While I am certainly no expert in the field
of biological monitoring, I suspect that a good deal of research is needed
in this area before we can have any confidence in a company's claim that a
large-scale release biotechnology has been confined to its appropriate
"place."
Finally, a monitoring mechanism should be capable of detecting actual
instances of human and environmental harm due to exposure to genetically
engineered micro-organisms and their products and by-products. In addition
to recording systematic and unplanned exposure, a thorough monitoring
program should include periodic medical surveillance of exposed persons and
periodic monitoring of the surrounding environment.
One general problem that will no doubt arise in agency attempts to
acquire data from biotechnology companies is the issue of trade secrets.
Companies will be reluctant to disclose information to the general public on
the nature of the micro-organisms that they intend to use and market,
because competitors might use this information to market competing products
without having to undergo research and development expenditures. Preserving
the competitive advantage of someone who has made a useful discovery can
protect incentives to develop important new products.
One solution to the "trade secret" enigma is to allow agencies to
collect commercially sensitive information, but prohibit them from releasing
that information. However, this solution requires the public to place its
entire trust in the agency's ability to assess the information and reach the
119
correct regulatory decisions. It also precludes the agency from thoroughly
supporting its determinations when they are attacked by regulatees.
Perhaps the best solution to the trade secret problem is a balancing
approach that weighs the public interest in disclosure of health and
environment related information against the privte interest in
nondisclosure. Since innovative micro-organisms can now be patented,
however, the balance should probably weigh in favor of disclosure. If a
firm elects to pursue the trade secret route rather than the patent route to
protecting its marlcet, it should be prepared to justify why members of the
public should not have access to information relevant to their health and
well-being .
B . Risk Assessment
An appropriate risk assessment of large-scale use of genetically
engineered micro-organisms would include at least two kinds of analyses.
First, genetically altered micro-organisms should be thoroughly
chracterized . This characterization should include analyses of the
structure of the organism's DNA, the ability of the altered organism to
infect humans and other organisms, the pathogenicity of the organisms, and
the possible by-products of the organism. If the organism could be
infective, an estimate should be made of the probability that human or
environmental exposure would be of sufficient duration and in sufficient
concentrations to creae a potential for damage in the infected entity.
Professor Martin Alexander has suggested a useful list of components of an
adequate risk analysis for large-scale release biotechnologies. He would
have the risk assessor examine the probabilities of the following five
events:
120
1. Environmental Release
2. Survival
3. Growth
4. Contact with Receptive Environment
5. Deleterious Effect*
To this I would add that the full social consequences of deleterious effects
should be factored into the risk assessment.
C. Regulatory Controls
At this early stage in the development of biotechnology, it is very
difficult to speculate upon the sorts of regulatory controls that might be
appropriate for keeping the risks within acceptable bounds. If risk
assessments of large-scale release biotechnologies reveal the need for
regulation, it may be advisable to examine some regulatory options available
to policymakers .
My preliminary conclusion is that regulation of large-scale release
biotechnologies should be implemented through a permitting mechanism under
which no use of such a technology would be lawful without a permit from an
appropriate regulatory agency. The entity requesting a permit would be
required to sustain the burden of demonstrating that the technology would
not cause unacceptable environmental effects. This would give the
regulatory agency good information on the extent to which the technology is
in use and it would place the burden of conducting the risk assessment or
the proponent on the technology.
« Dr. Martin Alexander, Spread of Organisms with Novel Genotypes,
presented to the Seminar Series on Biotechnology and the Environment,
conducted by th American Association for the Advancement of Science for the
U.S. Environmental Protection Agency, May 17, 1983.
121
Given the huge uncertainties that surround prediction of the
environmental effects of large-scale release biotechnologies and given the
potential for vast environmental harm, I believe that this stringent
regulatory device is proper. It must, however, be administered by an agency
that can command the public trust. The Atomic Energy Commission aNd Nuclear
Regulatory Commission experience demonstrates that if the agency lacks
public trust, licensing proceedings can rapidly degrade into expensive and
time consuming affairs that, in the end, resolve very little.
IV. CURRENTLY EXISTING REGULATORY REGIMES
Having drawn some preliminary conclusions about the elements of an
adequate regulatory regime, it is now appropriate to measure existing
regulatory structures against the ideal to determine whether any existing
agency or combination of agencies has sufficient authority to implement an
adequate reguatory program. If not, then it may be appropriate for Congress
to consider a separate regulatory program aimed at the new biotechnologies.
In making this assessment, I will focus primarily upon two statutes -- the
Toxic Substances Control Act (TSCA) and Section 361 of the Public Health
Service Act (PHSA) .*
* One predictable use of large-scale release biotechnologies is to
mitigate or kill pests. If a substance or mixture of substances is intended
to prevent, destroy, repel or mitigate a pest or to be used as a plant
reglator, defoliant, or desicant, then it may not be sold, distributed or
used until it is registered by the Environmental Protection Agency under the
Federal Insecticide, Fungicide, and Rodenticide Act. This statute is
precisely the sort of licensing statute that I have in mind for regulating
large-scale release biotechnologies. Thus, for large-scale release
biotechnologies that are pesticides, an adequately regulatory regime already
exists. Recent problems with the data base for existing pesticides,
however, might cause some concern about the ability of the Office of
Pesticide Programs in that agency to command public trust. See EPA
Pesticide Regulatory Program Study, Hearing before the Subcommittee on
Department Operation, Research and Foreign Agricuture of the House Committee
on Agriculture, 97th Cong., 2d Sess. (1982).
122
The Toxic Substances Control Act was enacted to provide a comprehensive
mechanism for addressing the hazards to health and the environment of
chemical substances. To date, however, EPA's implementation efforts have
been slow and halting. Nevertheless, the statute is a large repository of
regulatory power that EPA may draw upon when necessary.
TSCA regulates only chemical substances and mixtures . While TSCA is
clearly an appropriate vehicle for regulating chemical products and
by-products of biotechnologies, the ability of EPA to invoke the statute to
protect the public from the risk-s that the micro-organisms themselves create
depends upon whether the organisms come within the broad definition of
"chemical substance." TSCA defines that term broadly to include
any organic or inorganic substance of a particular molecular
identity, including . . . any combination of such substances
occurring in nature and any uncombined radical.
Although an entire micro-organism probably is not a "chemical
substance," the DMA molecule within a genetically engineered micro-organism
would seem to fit this statutory definition. The molecule has a particular
identity, even though that identity is not always ascertainable. Even if
the combination of genes does not "occur in nature," the DNA might come
within the definition of "mixture," which is defined as
any combination of two or more chemical substances if the
combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction.
Clearly, this question is ripe for litigation if EPA decides to regulate
the DNA of genetically engineered micro-organisms. If the courts refuse to
find that the DNA is a chemical substance or a mixture, then TSCA will be
largely unavailable to regulate industrial biotechnologies.
Section 361 of the Public Health Service Act gives the Food and Drug
Administration (FDA) broad authority to promulgate regulations in
123
cooperation with the Centers for Disease Control (CDC) to prevent the
introduction, transmission or spread of communicable diseases. The Surgeon
General of the Public Health Service may provide for inspection, fimigation,
disinfection, sanitation and other measures necessary to carry out these
rules .
A. Data Collecting and HonitorinR
1 . A Central Registry
As previously discussed, an essential element of a data collection and
monitoring system is a central registry of hosts, vectors, industrially
useful genetic sequences, products and byproducts. TSCA arguably gives EPA
authority to require firms using genetically engineered micro-organisms to
submit information necessary to compile an adequate registry, if the DNA in
a micro-organism can be characterized as a "chemical substance" or
"mixture." Under Section 5 of TSCA, the manufacturer of a new chemical
substance must submit to EPA a notice of its intention to manufacture or
process the substance. From this information, EPA could compile a registry
of commercially useful genetic sequences. It is less clear, however, that
section 5 would permit the agency to force companies to give it
premanufacture notification of hosts and vectors, because they would not,
under my reading of the statute, be considered chemical substances.
Should this application of section 5 of TSCA impose too great a burden
on new biotechnology companies, section 5(h)(4) permits EPA to exempt the
manufacture of any new chemical substance from all or part of the section 5
requirements if EPA determines that the substance will not present an
unreasonable risk.
2 . Surveillance of Technologies in Operation
Irrespective or whether EPA has authority to compile a central registry,
124
some agency should have the capability of gathering information on the
potential rislcs of biotechnology by monitoring, conducting inspections nd
requiring regulatees to Iceep accurate records. In addition, this
surveillance function would be essential for the enforcement of any
regulatory activity that the agency might undertake.
Section 8(a) of TSCA gives EPA blanket authority to require companies,
other than small manufacturers, to maintain such records and submit such
reports as EPA may reasonably require. This would appear to give EPA
adequate authority to require firms to inform it of systematic employee and
environmental exposure to genetically engeneered micro-organisms, their
products and byproducts. In addition, EPA has authority under Section
8(a) (2)CE) to require manufacturers to submit existing health and
environmental data, insofar as it is Icnown or reasonably ascertainable.
This authority could be used to provide EPA with existing studies on the
survivability of host organisms, attempts to characterize genetically
engineered micro-organisms, and risk, assessments performed on these
organisms .
Section 8(c) of TSCA independently requires manufacturers, processors
and distributors of chemical substances to maintain records of "significant
adverse reactions" to health or the environment alleged to have been caused
by a substance, and section 8(e) requires immediate EPA notification by
anyone who obtains information that "reasonably supports the conclusion"
that a substance or mixture "presents a substantial risk of injury to health
or the environment." These two provisions grant sufficient authority to
require biotechnology firms to report diseases and other adverse effects
caused by exposure to products and by-products of genetic technologies.
Whether they give EPA the power to compel inform.ation about diseases that
result from genetically engineered organisms depends upon whether it can be
125
said that the DNA (the chemical substance within those organisms) caused the
disease.
Section 4 of TSCA allows EPA to order companies to conduct testing on
chemical substances to determine their health and environmental effects if
it determines that
(i) the manufacture, distribution, processing, or disposal may
present an unreasonable risk.; and
(ii) there are insufficient data to predict the substance's
effects; and
(iii) testing is necessary to develop adequate data.
Under this section EPA could probably require testing for uncharacterized
micro-organisms .
C . Risk Assessment
EPA has authority to use information that it acquires to assess the
risks of newly emerging biotechnologies. Whether it can perform risk,
assessments as information becomes available depends upon wheter it develops
and uses the data aggressively. Although EPA presently has little expertise
in assessing microbiological risks, it is currently attempting to assemble
such expertise in the Office of Toxic Substances. The Center for Disease
Control is the nation's chief repository for determining the risks of
infective organisms. An interagency effort might best accomplish a holistic
assessment of all of the dangers posed by a particular large-scale release
biotechnology.
D. Regulatory Controls
TSCA and the PHSA provide the administering agencies with a large
arsenal of regulatory authority. If EPA determines that there is a
"reasonable basis to conclude that the manufacture, processing,
distribution, use or disposal" of a chemical substance will present an
"unreasonable risk of injury to health or the environment," it may apply the
39-383 O— 84 9
126
least burdensome of several requirements set forth in the statute.* In
addition, if EPA has a reasonable basis to conclude that a particular
manufacturer or processor is malting a chemical substance or mixture in a
manner that unintentionally creates an unreasonable risk., section 6(b)
allows EPA to require the submission of quality control procedures. If EPA
determines that those procedures are inadequate to prevent the substance
from presenting an unreasonable risk, the agency may order the manufacturer
to revise those procedures as necessary to remedy the inadequacy.
TSCA requires that the risk that a substance poses cross a designated
threshold. The Administrator must have a "reasonable basis to conclude"
that the substance will present an "unreasonable risk." The term
"unreasonable risk" connotes a balancing process. Of course, for a newly
emerging technology, both risks and benefits will be highly speculative, and
EPA will probably be given great leeway in making this threshold
determination .
^Nevertheless , TSCA is n ot a permitti ng statute. The proponent of a
technology does not have to apply to EPA for a permit to market that
EPA may apply:
(1) A requirement prohibiting the manufacture, processing, and distribution
of the substance entirely or for a particular use.
(2) A requirement limiting the amount of the substance which may be
manufactured, processed, and distributed.
(3) A labeling or warning requirement.
(4) A recordkeeping requirement.
(5) A monitoring requirement.
(6) A requirement prohibiting or otherwise regulating any manner or method
of commercial use of the substance.
(7) A requirement prohibiting or otherwise regulating any manner or method
of disposal of the substance.
(8) A requirement directing manufacturers or processors to give notice to
the public and to distributors of such unreasonable risks and to replace or
repurchase such substances as elected by the recipient of the notice.
127
technology. Unless EPA acts on the basis of information it receives under
section/4 and 5 within a relatively brief period of time, the proponent of a
technology may marlcet that technology until such time as EPA can make the
"unreasonable risk" threshold showing. The burden is on EPA to support the 'jC
statutory finding. Given the large uncertainties that surround any attempt
to assess the risks of large-scale release biotedmaLo^ies . this burden may
be very difficult to meet in practice.
If the courts hold that genetically altered DNA in a host cell is not a
"chemical substance," then section 361 of the PHSA is available to protect
humans from communicable disease. Although this provision does not give FDA
authority to regulate products and by-products, its unusually broad scope
authorizes rules to protect humans from the risks of infection caused by
genetic enginering micro-organisms. The courts have upheld broad
interpretations of section 361 based primarily upon the asserted need to
protect the public from exposure to contagious disease.
On the other hand, section 361 refers explicitly only to human beings.
While damage to the environment often manifests itself in the form of public
health problems, other ecological spoilage has only a tenuous link to public
health. Arguably, however, once an agency has established "jurisdiction"
over a substance, it should have authority under the National Environmental
Policy Act to protect the environment as well. Furthermore, the Department
of Agriculture might be able to protect non-human plants and animals by
invoking the animal quarantine laws and the Federal Plant Pest Act. This
statute is similar in structure and purpose to section 361.
The real problem of depending upon the PSHA to regulate biotechnology is
that of resources. While the Public Health Service has a deep reservoir of
expertise on communicable diseases, it is not really designed to prescribe
128
health and environmental standards or to license technologies. On the other
hand, section 361 offers the greatest flexibility to select the most
appropriate regulatory strategies for various genetic engineering
technologies.
V. THE NEED FOR A SEPARATE STATUTE
The foregoing examination of statutory authority demonstrates that
federal agencies probably have sufficient regulatory power to acquire
information relevant to the risks posed by industrial use of genetic
engineering technologies and to protect the public health and the
environment if risk assessments demonstrate that regulation is necessary.
The current statutory arsenal, however, is not without its weaknesses. Some
of the most effective statutes, such as the Federal Insecticide, Fungicide,
and Rodenticide Act, apply only to risks associated with the manufacture,
distribution, and use of particular products. Other more comprehensive
statutes -- the Clean Air Act, Clean Water Act, the Resource Conservation
and Recovery Act, section 361 of the PHSA, and the Occupational Safety and
Health Act, for example -- relate to particular risks. Only TSCA provides a
comprehensive weapon that can target all risks and all stages of production.
The linchpin of a regulatory strategy that relies on TSCA is the
validity of the assumption that the DNA in a micro-organism is a chemical
substance or mixture. The argument for regulating micro-organisms through
their DNA is convincing but risky.) Hence, the only way to ensure adequate
mo
nitoring and regulation of the emerging biotechnologies may be to enact a
statute that specifically addresses those technologies^ A separate statute
would give Congress or a state legislature the opportunity to craft
reporting, testing, and regulatory requirements to the precise needs of the
129
new technology, rather than force an agency to attempt to fit the issues
into an unsatisfactory statutory mold. By enacting new legislation,
Congress also could choose the appropriate regulatory agency or create a new
one. Because it would focus exclusively upon a single technology, the
agency or subagency unit could rapidly acquire expertise in the technology
and its rislts. A new statute aimed at large-scale release technologies
could adopt the permit approach, which minimizes the probability that
harm-producing large-scale release biotechnologies will cause harm to the
natural environment.
Strong arguments, however, oppose creating a new regulatory regime.
Since the relevant technologies are new and rapidly evolving, disagreement
undoubtedly will arise over what constitutes the approprite elements for the
statute. A changing legislative problem is not always conducive to
intelligent draftsmanship. Although precedent abounds for aiming regulatory
regimes at particular technologies -- for example, nuclear power and radio
and television communications -- the technique has important disadvantages.
The close interaction between the agency or subagency unit and the regulated
industry could breed a familiarity that ultimately could mature into
captivity. At the other extreme, the regulatory program, to justify its
existence, might feel pressure to regulate unnecessarily. Finally, absent
some crisis or other incident that brings the potential rislts of new
biotechnologies forcefully to the attention of the public, the issue
probably will not generate enough enthusiasm to propel a bill through
Congress .
Perhaps the most effective action that Congress could take at this
juncture would be to amend the defintion of "chemical substance" in the
Toxic Substances Control Act to eliminate any doubt that Congress intends
for EPA to use TSCA's comprehensive regulatory process to regulate the risks
posed by large-scale release biotechnologies.
130
Testimony to the Subcommittee on
Toxic Substances and Environmental Oversight of the Committee on
Environment and Public Works of the United States Senate on the Topic:
The Intentional Release of Genetically Engineered Organisms
Washington, D.C.
September 27, 1984
David A. Jackson, Ph.D.
Senior Vice President
Genex Corporation
Rockville, Maryland
131
The subject of the release of genetically engineered organisms into the
environment, whether that release is intentional or inadvertent, h^s had a
rather contentious history. In my view, some of the contention is^ legitimate
in the sense that the contending parties are well informed as to the technical
realities of the situation but simply come to different, honestly held conclu-
sions regarding the likely outcome of the set actions, or simply disagree about
what constitutes an acceptable degree of risk in a given situation. A signifi-
cant amount of the contention is due to lack of understanding on the part of
some of the contending parties regarding various technical issues. Finally,
some of the contention is accompanied by the unmistakable sound of axes being
ground in the background.
In my testimony, I wish to make several points which I believe are relevant
to the release of genetically engineered organisms into the environment, and
to what is the appropriate role of the federal government in regulating such
releases. The first and most important point is that genetic engineering is a
technology, not a new scientific discipline. It is a process, not an end result.
It is possible to modify many organisms genetically using either conventional
genetics or genetic engineering and to arrive at precisely the same result. It
follows, therefore, that questions directed to the advisability of releasing an
organism into the environment should be directed to the characteristics of the
organism (including its genetic stability) and not to how the genetic character-
istics of the organism were developed.
A second point which follows from the first is that a focus on whether only
genetically engineered organisms required new federal regulatory mechanisms
will almost certainly lead to bizarre, inconsistent, and indefensible regulation.
132
Indeed, it has already done so, as I shall explain below. A third point is that
the environment or biosphere contains in it many mechanisms to keep it in balance.
Some of these we understand and some we do not. However, it is ir§ general (but
not always) the case that most perturbations of the environment are resisted by
these mechanisms, which tend to maintain whatever equilibrium has been established.
Thus, in general (but not always), introduction of a new organism into the envi-
ronment will be resisted by the mechanisms which maintain the environment in
equilibrium. This will especially be the case if the organism has been geneti-
cally engineered to be a specialist at doing one particular thing well. Such
specialization is not without cost to the organism, and it is a matter of experi-
mental fact that most genetically engineered microorganisms survive very poorly
in competition with naturally occurring microorganisms. This is not because
they are genetically engineered per se but because the genetic engineers have
tried to make them as efficiently specialized as possible for economic reasons,
leaving them unfit to function well in any but the highly specialized environ-
ment of a fermentation medium. Microorganisms similarly modified using conven-
tional genetic techniques have exactly the same problems competing in a natural
envi ronment.
Let me now elaborate on these points. Many people believe that an organism
which has been modified by genetic engineering is somehow wholly different from
normal organisms or variants of normal organisms obtained by conventional genetic
mutation and selection or by breeding programs using conventional techniques.
This is simply incorrect. It is true that it is possible to construct organisms
using genetic engineering techniques which are modified in ways that would occur
at most very infrequently in nature, but it is also possible to use these tech-
niques as an alternative and more efficient means of constructing genetically
133
modified organisms which were previously constructed by conventional genetic
techniques. In this latter case, it is perfectly possible that the two organ-
isms which result from the modification by the two different sets l)f techniques
will be literally identical. In such a case, it would be very difficult to
argue that one organism should be regulated differently from the other simply
because a particular set of techniques had been used to construct it.
It is useful to consider why so many people believe that genetic engineer-
ing confers some sort of special properties on an organism. There are, I be-
lieve, a series of reasons. The first is that not many people have taken a
course in molecular genetics, and such a course is necessary to understand many
of the technical realities of genetics and genetic engineering. The second is
that our cultural heritage includes a large literature in which the process of
genetic engineering in its broadest sense _i_s assumed, either explicitly or im-
plicitly, to confer special properties on the resulting organism. This litera-
ture goes back at least to Frankenstein , and includes more recent works such
as Brave New Korld , The Andromeda Strain , The Boys From Brazil , and a large
segment of contemporary science fiction. We thus are educated to a world view
which, unfortunately, happens to be incorrect. The third reason I think we
worry especially about genetic engineering was summed up most succinctly by
Professor George Wald of Harvard who said "A living organism is forever." The
notion is that mistakes in genetic engineering are likely to be particularly
bad, because they are irreversible. However, this notion and its statement by
Professor Wald, while attractively dramatic, does not fit the facts. Professor
Wald is a distinquished scientist, but he cannot have been thinking about evolu-
tion, natural selection, survival of the fittest, extinction, and so forth when
he said "A living organism is forever." We of course know that many hundreds
134
of thousands of species have become extinct during the course of evolution, by
virtue of not being able to compete effectively in the natural environment. The
vast majority of genetically engineered organisms are likely to sliare this in-
ability to compete effectively, in large part because they have been designed
with other purposes in mind.
The current controversy regarding field testing of so-called "ice-minus"
bacteria can be used to illustrate another point made above: how focussing on
whether an organism has been modified by genetic engineering rather than on what
the properties of the organism are has resulted in policies which are logically
inconsistent. Ice-minus bacteria are variants of either of two species of micro-
organisms, Pseudomonas syringae and Erwinia herbicola , which lack the abi lity of
the parent microorganisms to promote the formation of ice crystals in supercooled
water. The ice nucleation activity of the parent microorganisms is responsible
for a substantial amount of the frost damage done to crops by temperatures in
the range of 24° to 28°F. The ice-minus variants, which occur naturally or which
can be produced by modifying the parent microorganisms using genetic engineering
techniques, do not promote frost damage on plants they colonize. Moreover, if
the ice-minus variants are sprayed on the plants at appropriate times, they are
able to reduce the population size of the ice-nucleating parent microorganisms
to the point that frost damage is substantially reduced. This information has
been obtained from experiments using naturally occurring ice-minus variants in
laboratories, greenhouses, and field trials. Experiments with genetically en-
gineered ice-minus variants in laboratories and greenhouses have confirmed that
these organisms behave in the same manner as the naturally occurring ice-minus
variants. Field trials of the genetically engineered variants, however, have
been the subject of much dispute and are presently prohibited.
135
The ostensible reason for prohibiting field trials of the genetically engi-
neered ice-minus variants is that their effects are unknown and might be damag-
ing to the environment. One is forced to conclude, however, that athe real
reason for prohibition is that the organisms are genetically engineered. As
mentioned above, field trials with naturally occurring ice-minus variants have
already been performed. So far as I am aware, there have been been no claims
of any harmful effects arising from these field trials and there is no prohibi-
tion on repeating these trials with an organism which has been modified by con-
ventional genetic techniques rather than by genetic engineering techniques.
Situations as obviously inconsistent as this make for bad regulation. If ice-
minus bacteria are harmful, they should not be placed in large quantities into
the environment irrespective of how they are prepared. Similarly, if they are
not harmful, the fact that they have been prepared using genetic engineering
techniques is immaterial. Finally, it is worth noting that other biological
techniques for reducing the damage caused by Pseudomonas syringae -promoted ice
nucleation have also been developed. One such technique involves spraying crops
with suspensions of bacterial viruses which grow on and kill Pseudomonas syringae .
These naturally occurring viruses, in killing a whole population of bacteria, un-
doubtedly introduce an ecological perturbation, and probably a significantly
larger one than the introduction of so-called ice-minus bacteria which differ
from normal microorganisms by only one or a few genes. I wish to emphasize that
I am not taking a position as to the relative safety or efficacy of the various
biological approaches to dealing with crop damage promoted by ice-nucleating bac-
teria. What I am saying is that safety and efficacy should be the basis for
regulatory action, not the mechanisms by which the organisms have been modified,
unless those mechanisms can be demonstrated to affect safety and efficacy.
136
In order for regulation of products produced by biotechnology to achieve
the desired result of safety in a manner that can be administered and defended
as being logically consistent, it is important to recognize that there is not
a genetic engineering or biotechnology industry per se . Rather, there are a
large number of companies using new techniques of biotechnology, including, but
by no means limited to, genetic engineering techniques, to make a wide and grow-
ing diversity of products. The vast majority of these products fall into cate-
gories currently regulated by FUA or EPA or USDA. In these categories, regula-
tion is generally on the basis of the product's characteristics and the uses to
which it is to be put, which is as it should be, and not on the basis of the
technology used to produce the product. 1 see no reason why this present regu-
latory structure needs to be fundamentally altered for products produced in,
containing, or consisting of genetically engineered organisms. Similarly, if
such products are to be released into the environment, there is no reason I know
of why the present regulatory structure is fundamentally inadequate to evaluate
and appropriately regulate such releases.
This is not to say that present regulatory mechanisms or agencies are ideal
or that they function as well as they might. For instance, if the EPA is going
to be involved in regulating the release of products produced using genetic en-
gineering, as would seem appropriate given its charter, then the agency will
need more personnel who are familiar with this technology that it now has. The
EPA will need to develop the same level of internal expertise with respect to
genetically engineered organisms that the FDA has already done. To the agency's
credit, I believe it recognizes this need and is moving to fill it. Because
the agency is now drafting regulations which would apply to products made using
genetically engineered organisms, and to release of such products into the
137
environment, it is important that these personnel be provided sooner rather
than later. A similar need exists at USDA. The regulatory agencies are being
asked to cope with a host of new products made possible by rapidly developing
new technology. They need help to carry out their mission effectively.
In the short term such help can perhaps cone in part from the Recombinant
Advisory Committee (RAC). The RAC, the rest of NIH, the NSF, and the FUA are
clearly the major loci of technical expertise in biotechnology in the federal
government at the present time. However, except for FDA, these agencies are not
regulatory agencies and lack the expertise in regulation which is just as impor-
tant as technical expertise. Perhaps, at least as a temporary measure, an inter-
agency group incorporating the RAC and supplemented by members from the major
regulatory agencies which will have to deal with biotechnology, could serve both
as a source of expertise on biotechnology and as a clearinghouse which would
help advise the regulatory agencies in situations where jurisdictions may appear
to overlap.
In concluding my testimony, I would like to make one more major point.
There have been several calls for prevention of any deliberate release of genet-
ically engineered microorganisms into the environment until we understand the
ecological situation better and have a better predictive capability with regard
to the outcome of the release. As a scientist, I must ask "Where is this better
understanding and predictive capability going to come from?" The data upon which
better predictions can be based must come from experiments. Science gains its
better understanding of the world in which we live by doing experiments, and by
definition the outcome of an experiment is not predictable in advance. A call
for a ban on experiments in a particular field is a prescription for paralysis
in that field. This does not mean that scientists or others have the right to
perform any experiment at any time. It does mean that we as a society must ac-
cept some measure of risk in order to foster progress, and that werwust not doom
ourselves to stagnation and paralysis by chasing the unobtainable goal of a
zero-risk world.
138
Testimony of Daniel Simberloff on potential ecological effects of
releasing genetically engineered organisms, for hearing on "The
Intentional Release of Genetically Engineered Organisms" by the
Subcommittee on Toxic Substances and Environmental Oversight (Sen.
Dave Durenberger, Chairman) of the Senate Committee on Environment
Public Works, September 27, 1984, Washington, D.C.
and
AjA-^^f
Dani el Simber lof
September 18, 1984
INTRODUCTION
I am an evolutionary ecologist, and among topics that I have
studied are: 1) how ecological communities are organized, 2) the
effects of introduced species on ecological communities, and 3) the
ecological effects of genetic change (evolution) of native species on
their communi ties.
The gist of my testimony is this: There is a popular misconception
that ecological communities are stable, saturated entities, with all
"ecological niches" filled, and no room for new organisms - either
exotic species, introduced from other regions, or native species that
have new genes. Furthermore, this view of nature suggests that
communities are robustly organized, with each species held in check by
its interactions with predators, parasites, pathogenic microorganisms,
etc. A new organism would thus be unlikely to have much of an effect
on a community: there would be few resources available to it, and it
would not be adapted to deal with the host of enemies that it would
encounter .
This view of a robustly balanced nature may be appealing and
comforting to us, but it is incorrect. Ecologists have amassed
evidence that communities are never full; there are always new ways to
make a living if the right new species or new genotype of a native
species comes along. Strong evidence for this assertion comes from
studies of introduced species and of slightly changed native species.
These two kinds of events - new species and new genotypes of native
species - are not qualitatively different. In both instances, a
community is faced with a novel biological entity. In both instances,
the new element may not even be able to survive, and, if it does
survive, it may not have a major impact on the existing components of
the community. There have, however, been disastrous effects of both
sorts of events, and a new genotype of an
a new species, even if the genetic change
Thus, the events are ends of a continuum,
together .
existing species may become
is initially very slight,
and should be considered
I contend that release of genetically engineered organisms into
the environment is clearly part of this continuum. I n fact, it is
f rom an eco 1 o g i c a 1
occurs "naTt lF d 1 1 y
standpoint exactly the same as w nen a new mu ta n t
d native spe<!l g-rr — F r u iii — tire — luiihiiuii i Ly*^
sxandpoint, Tl does not matter how the new genotype arose, just that
139
it now exists, and the community will have to deal with it in some
way. Ecologists and evolutionary biologists possess sufficient
expertise that, together with other specialists, they would be able to
implement assessment and monitoring procedures that would minimize the
possibility of ecological damage. Such procedures would have to be —
rigorous and time-consuming, but the potential for economic damage is/
so great in their absence that they should be instituted immediately.?
GENETIC CHANGES IN NATIVE ORGANISMS, AND THEIR ECOLOGICAL EFFECTS
When an event happens in nature, as opposed to in a controlled
experiment in the laboratory, it is always much more difficult to
describe it with absolute assurance. Thus I cannot say, in any one of
the examples that follow, that we can be completely certain that
genetic change is the only cause for the subsequent ecological damage,
or that we have described the nature of the genetic change fully. I
can say, however, that in each example the evidence for the key role
of "genetic change is compelling, and that in some of these cases there
has been sufficiently detailed genetic research to be certain that the
genetics is a very large part of the story, if not the whole story.
The apple maggot, Rha£o2etJ_s ££!I!on£21a. is a good example, studied
in detail by Bush (1969, 1974). This fly is an economically important
pest of apple, but was originally almost wholly restricted to a
different plant, hawthorn. It was not even found on apple trees that
were present with hawthorn. Then, suddenly, in 1865, it was reported
attacking apples in the Hudson River Valley, and a little later in
southern New England. From this focal point, the apple race, which
may even qualify as a separate species, has spread to be found over
the whole northeastern and central part of the U.S. Bush feels that
the original host shift from hawthorn to apple rested on a single
mutation, and that this kind of event may have occurred much more
frequently in the history of life, and may account for the large
number of closely related insect species that attack different host
plants. The only thing that is special about this particular case is
that there were sufficiently good records of the host shift, and the
possibility of genetic analysis of many of the traits of this fly, so
that it W2J possible to rprnnstrurt what happened.
Another example, without a strong genetic analysis to support it,
but with clear records of a sudden change in the geographic range of a
species, is the collared dove, Stre£t0£e22i deca£ct£, a European and
Asian bird originally restricted to the Balkans. It lived in parts of
the Balkans for over 200 years and showed no inclination whatsoever to
spread (Mayr 1963). Suddenly, at the end of the I920's a few
individuals were found in Hungary, then western Yugoslavia, then
Austria, and now they are a pest al 1 over western Europe. A similar
expansion occurred in its Asian range (Nowak 1975). Not only was
there no help from humans, but the expansion occurred in spite of
tremendous hunting and other measures that slowed it down. Mayr
suggests that a mutation is probably the reason, one that ca uses
individuals not to home as strongly as they orginal ly nag . He
sTTggTTrs a s i mi 1 ar scenario for another European bird, Oie serin
{SerJ_nus canaria) that suddenly expanded its range, and there are
other reports ifi the European literature for rapid range expansion of
140
a bird and a hamster in which a single genetic mutation is claimed to
be the cause (Nowak 1975).
Southern maize leaf blight (H£j.!!!J.Ill!l£l££liiiII! mil^ll) > ^ fungus
that devastated the corn crop in the southeastern U.S. in 1970, is
another good candidate for swift genetic change. Since the 1940's
corn breeders had been using cytoplasmic male sterility in the
production of hybrid corn seed. The particular cytoplasm they used
made the plant susceptible to the blight, yet the blight did not occur
until 1970. The immediate cause of the epidemic has not been
conclusively established (Vanderplank 1978), but it is known that
favorable weather is an insufficient explanation and that there was a
genetic change in the fungus itself from a race (0) that- was not of
much consequence to a race (T) that produces characteristic toxins and
that causes different symptoms.
The rice brown planthopper (N22£££IX^li IH3£I1^) ^^ ^ major pest of
rice in Asia, and the contr i but i on~of quTck genetTc change to its pest
status has been thoroughly studied (Sogawa 1982). Until recently this
insect was a minor problem, but in the early 1970's a severe
infestation occurred in the experimental farms of the International
Rice Research Institute in the Philippines. Not only did the
planthopper itself cause damage, but it transmitted harmful viruses as
well. The outbreak quickly spread to Indonesia, then to the Indian
subcontinent. It has been established that the cause was genetic. In
brief, rice has several sets of "resistance" genes that resist the
effect of the insect, but, as quickly as these resistance genes spread
through the rice population, "virulence" genes arise in the insect and
overcome the resistance by the plant.
The Hessian fly (Ma^et2o2a des^tructor) is originally from Europe,
and so is not a native species in the U.S., but it has undergone
genetic change in the U.S. that has made it a dangerous pest of wheat,
and the way in which this change has come about is very similar to the
scenario that I just sketched for the rice brown planthopper (Diehl
and Bush 1984). There are complexes of resistance genes in wheat and
_v^irulence genes in the fly. Historically, what has happened is that
resistance genes increase in frequency (lessening damage to the wheat
crop), but virulence genes eventually increase in frequency in the fly
and it becomes a problem again.
One can easily see that the examples of the rice brown planthopper
and the Hessian fly are quite analogous to the well known problem of
the development of pesticide resistance in many insects. Because
pesticide resistance occurred so recently, and in so many economically
important insects, and because the chemistry and node of action of
pesticides are usually well established, it is much easier to trace
the genetic basis of pesticide resistance than it is to unravel the
causes of sudden changes in species in nature. Resistant strains had
evol. ied in 364 arthropod species by I'i?^, .^nf^ thp'^p pp<.t s wr^re
res istant to atleast 57 pesticides (Georghiou and Ta y lo r 1976). The
dTVastating e c o'l o g i c a 1 disruption, healtheffects, Fi n fi n C 1 d 1 — ^o^-s-, and
socioeconomic effects are well known, and are enumerated by Georghiou
and Taylor (1976) and Sharpies (19S3), so that I need not repeat them
here. I would like to elaborate on resistance, however, to show how o
141
small genetic change can lead
and importance in an ecological
structure and function of the e
to a dramatic change in a species' role C
community, and can even disrupt the f
entire commun i t y. ^
Many i nsects become resistant to pesticides by a very simp l e
means. "'TFe'v have a sufficient number of genes in their population? ,
aTra~trfrey~h''a^Te'~a~ su?f ici ent 1 y high natural mutation rate, that they
either have or quickly produce genes that confer resistance to almost
all chemicals that humans can challenge them with. \T h e p e s t i cj ji e
i tse 1 f bee om es the agent of natural selection that causes the rapj ^d
ev olution ot resista nce , a <i i nH i » i riii;:i 1 <: th^t havp r p «; i s_ta£Cje genes
s ur V i ve and repr od uce at a higher rat e th^" thn<;p that lack such
enes. The frequency of the resistance genes thus increas e s, aKB
number of generations of this process, the vast majority of
have these genes and are resistant.
^
aTrer a
individuals
The
ley can
n the b
void ae
?rmeabi
F the 1
;s i Stan
jthway ,
lange s
isect r
izyme m
I Chang
lth.oii.aJi
;en fou
genes that confer resistance are of many different types,
affect behavior - for example, they can cause insects to sit
ottoms of leaves instead of the upper surface, and thus to
rially dispersed pesticides. They can affect membrane
lity, so that the pesticide cannot reach the organ or tissue
nsect where it would act. Most often, the gene that confers
ce does so by causing a slight change in a biochemical
rendering the pesticide less damaging. A target enzyme may
lightly, so it still performs the catalytic function that the
equires, but is less sensitive to damage by the pesticide. An
ay be slightly modified so that it detoxifies the pesticide,
i n g 2 1 s^ chemical structure and rendering it innocuous.
— l-ti-e_e_xa_ct_mean_s_of rps i^tanrp are manv. they have usuall y
nd to be 'due'T°lJi' q^ ^ genes (Brown 1977). For example, DDT-
■reTTsTalTce involves at TeTstthree mechanisms, each controlled by a
single gene. Two of these mechanisms change the DDT molecule, and the
third renders the insect's nerves less sensitive.
A resistant pest can wreak havoc with an agricultural or natural
community. The most common way in which this comes about is that
those predators and parasites that had helped to keep it under control
are themselves greatly reduced in numbers by the same pesticide that
selected for resistance in the pest. The predators and parasites do
not usually themselves evolve resistance nearly as rapidly, largely
because they are present originally in much lower numbers and
therefore are much less likely to have the resistant genes present in
their populations for natural selection to work on. Without predators
and parasites, the resistant pests can increase in number many-fold,
outcompeting non-resistant species, reducing the populations of plants
that they specialize on, and generally disrupting the community. The
devastation brought about by the development of resistance to
organoch 1 or i ne pesticides by the boll weevil (Anthonomus ^r_sndi_s) and
the tobacco budworm (He21othis z^ea) and boll worm (HeJTothrs ~
virescens) in Texas are welT" chroni c 1 ed (Sharpies 1983). A less
wTJeTy publicized effect is that resistant insect vectors spread
disease. Thus resistance is a public health catastrophe (Pal 1976).
Since diseases are among the natural forces that help to control
species in natural communities, increased numbers of some disease
vector can work to the severe disadvantage of those species
39-383 O— 84 10
142
susceptible to the disease and to the advantage of species that are
unaffected by the disease. So the effect of resistance on disease
rates has ecological consequences.
To summarize this section: Changes in one or a few genes happen
all the time to species in nature. Host of these naturally occurring
mutations are of no ecological consequence, since they render the
organism much less fit and natural selection weeds out the mutation
(Mayr 1963). However, occasionally a naturally occurring mutation
confers an advantage on the organisms that have it, by allowing them
to use some kind of resource that they have not used before, or to
survive against some kind of mortality factor that had previously
ki 1 led them. The spread of such a mutation would occur under any
circumstances, but sometimes it is accelerated by human activity. In
any event, a species that had not been a pest may thus become a pest;
it may even produce a new species (as when the maggot on hawthorn
colonized apple). Part of what happens when a species becomes a pest
is that it becomes much more numerous. Often it also expands its
geographic range, and/or begins to use new resources and habitats.
All of these events cause it to interact in different ways with the
species in natural communities - it may devastate some of these
species and aid others. The ecological effects can therefore be
enormous. All of these possibilities have been realized in some
instances - they are not just hypothetical.
ECOLOGICAL EFFECTS OF INTRODUCED SPECIES
Just as a genetic change in a native species presents a challenge
to the ecological community, so does the introduction of a new
species. Many introductions of new species have become classic
ecological horror stories. Some of these - the gypsy moth, the
Japanese beetle, the water hyacinth, the starling - are well-known to
all Americans. Introduced pests such as these have obvious effects,
but there are also subtle ways in which introduced species can have
great ecological consequences. One example is the fungus Endothia
parr s2t2ca, the chestnut blight (Sharpies 1983). Asian chesTnuFs are
lltOe affected by this Asian species, and American species of
Endothj_a are not major pests of the American chestnut (Ca^s^tanea
HnIlIlT that harbors them. The Asian fungus, however, was so deadly
to the American tree that it had killed almost all American chestnuts
by 1950. Shugart and West (1977) attempted to model the changes in
forest structure and function that occurred when the chestnut was
suddenly removed. It was one of the most widespread of all
Appalachian trees, and, by virtue of its vegetative reproduction, fast
growth, and shade-tolerance, was probably important in aiding general
forest recovery after disturbance. Though the number of trees does
not change much after chestnut blight, the species composition and the
functioning of the forest are greatly changed. Nutrient cycling in
the forest floor, production rates, and gas exchange are all affected.
These changes are in addition to the obvious consequences of removing
a tree that was used by wildlife (especially for its nuts) and by the
timber industry.
Most introduced species do not
subtle or apparent. Most of them.
have such drastic effects, either
in fact, do not survive. There are
143
no valid statistics on the fraction of introduced species that
survive, since most introductions are not recorded, whether they occur
naturally (as when the cattle egret colonized the United States) or by
human transport. Introductions are especially unlikely to be recorded
when they are unsuccessful (that is, when the introduced species fails
to survive for long). I have, however, surveyed 854 inst ances of
species being introduced into new regions where the i ntroduced species
survived, and where there are sufficient records to attempt to see
what happened (Simberloff 1981). >Thp mn<;t strii'ing ro^nit , was that.
u suj 1 l_y ^ noth ing dramatic happened. In 678 of these 854 cases the
effect~on the^r"eTTTenT~C'?rnrrira7rrt7— was so slight that one could not
point with assurance to a single consequence of the introduction.
Part of this result is simply ignorance; without performing exhaustive
experiments and taking massive field data on all species in the
community, one cannot know for sure what effects the introduction had.
However, it is possible to say in these 678 cases that there was no
change major enough that casual and/or partial scientific examination
by trained ecologists turned it up.
The remaining 176 introductions produced a variety of
changes in the ecological communities that received them.
71 extinctions of native species, most of these brought a
predation of the introduced species on a native species,
destruction by the introduced species also often contribu
extinction of a native form. Many other effects occurred
frequently. For example, some native Hawaiian birds have
extinguished by diseases carried by introduced birds, sue
In some instances this extinction by disease also require
insects, mosquitoes, to act as vectors. In addition to e
there were a variety of less extreme effects caused by th
introduced species - through habitat destruction, predati
competition, vectoring of disease, parasitism, and other
reduced populations of one or more native species and thu
structure of the community, sometimes substantially. A g
of the community ecological effects of many introduced sp
published by Elton (1958).
ecological
There were
bout by
Habitat
ted to
less
been
h as pou 1 try.
d introduced
xt i net i ons,
ese
on ,
means, they
s changed the
ood summary
ecies was
There dc not appear to be any single traits that characterize
those communities that are particularly subject to disruption from
introductions, or those sorts of species that are especially likely to
cause problems. C Two kinds of ecological communities that see m
pa rticularly prone to damage from new species are a grirultuTTl
c ommunities and island communities, but there are many examoles wher e
bo th sorts of community do not suffer greatly from particula r
i Ftroduct ions , and there are also manv examples where comole^Le 1 y
d ifferent sorts of communities are greatly affert pd. A careful
examination of each case reveals Tdiosyncr atic aspects of the biology
of particular species, and of int e r a c CToTTs^ b etween "species, that
determine whether a particular introduction will or will not cause
damage. This is not to say that there is no way to predict what
harmful effects an introduction might have. In retrospect, a careful
ecological study of the native community and of the proposed
introduced species would, in most instances, have revealed the danger
that was later realized.
144
HOW TO MINIMIZE THE POTENTIAL FOR ECOLOGICAL DISRUPTION
Genetic engineering offers the pro^iise of great benefits to
humankind, especially in the areas of health, agriculture, and
environmental management. Some introduced species have been very
helpful to us. One need only think of the many fruits and vegetables
that are staple foods; most of them are not native to the Americas.
Or one can consider the many millions of dollars that are saved each
year by biological control - the use of introduced predators and
parasites to control damaging insects. Similarly, new genotypes
created by science have been of great benefit - plant and animal
breeders have increased food production enormously by genetic
mani pu lat ion .
But just as novel genotypes of native species and introduction of
new species have at times caused staggering ecological problems, so
are such disasters possible from the release of new genotypes produced
by the most recent means of genetic engineering. Research is underway
to increase the resistance of crop plants to insects and pathogens; to
extend the range or increase the virulence of bacterial pathogens of
insect pests; to extend the range of physical and chemical conditions
that will allow plant growth; and to broaden the range of substrates
that will support the growth of microorganisms. Many of the new
genotypes that will be produced in pursuit of these goals will be
completely different from anything that nature has already produce
natural means of mutations. Changes such as these may allow the
engineered organism to escape from one form or another of natural
limitation on population growth, habitat range, or geographic rang
and thus to cause the sorts of ecological damage that I have discu
above for new genotypes of native species and for introduced speci
d by
e,
ssed
es.
All this is not^ to say that the spectre of release of ecologically
engineered organisms is so grim that it must be prevented. It does
suggest, however, that there are potential dangers and that great
caution is needed. Ecologists and evolutionary biologists possess
sufficient expertise that, in concert with other specialists, they can
design and implement assessment procedures that will minimize (though
never completely eliminate) the likelihood that a particular release
will lead to major ecological damage. Analogous procedures are
already in use in, for example, the testing of new pharmaceuticals
required by the F.D.A. or in the environmental impact statements
mandated by the N.E.P.A. As in these cases, risk assessment will
always have to be on a case by case basis. However, the fol lowing
potential adverse effects should always be considered:
I) Evolutionary
a) Likelihood and nature of host range shifts.
b) Likelihood of unregulated propagation.
c) Likelihood of changes in virulence of parasites and
pathogens .
2) Ecological
a) Effects on competitors.
145
b) Effects on prey, host, and symbiotic species.
c) Effects of predators, pathogens, and parasites,
d) Role of new organism as vector of pathogens.
e) Effects on ecosystem processes, such as cycling of
bi ogeochemi cal s .
f ) Effects on habitat.
Finally, the release should be followed by a continuous process of
monitoring for changes in the released organism and the community. A
sufficient commitment of economic and human resources to a program of
this sort would prevent some ecological crises that will almost
certainly develop in its absence, and will minimize the possibility of
unexpected problems. Whenever a se 1 f -reproduc i ng entity, such as a
genetically engineered organism, is released into nature, the
difficulty of subsequent control once we learn we have made a mistake
is so great that the most stringent pre-release safeguards are
warranted .
REFERENCES
Brown, A.W.A. 1976. Epilogue: Resistance as a factor in pesticide
management. Pp. 816-824 in Proc. XV Internat. Congr. Entomology.
Entomological Society of America, College Park, Md.
Bush, G.L. 1969. Sympatric host race formation and speciation in
frugivorous flies of the genus Rha£o2et_i_s (Diptera, Tephr i tidae).
Evolution 23: 237-251.
Bush, G.L. 1974. The mechanism of sympatric host race formation in the
true fruit flies (Tephritidae). Pp. 3-23 in Genetic Mechanisms
of S£ec2atJ_on j_n Insects, ed. H.J.D. White. Australian and New
ZeaTanH BooF Co., ^yHney.
Diehl, S.R., and G.L. Bush. 1984. An evolutionary and applied
perspective of insect biotypes. Annu. Rev. Entomol. 29: 471-504.
Elton, C.S. 1958. The Eco]_03y^ of^ illi3si_ons b^ AHlEIill iHl Plgpts .
Chapman and Hall, London.
Georghio", 6. P., and C.E. Taylor. 1976. Pesticide resistance as an
evolutionary phenomenon. Pp. 759-785 in Proc. XV Internat. Congr.
Entomology. Entomological Society of America, College Park, Md.
Mayr, E. 1963. Anima^ S£ecJ_es and Evolution. Harvard University
Press, CambrTJge, Hass.
Nowak, E. 1975. The range expansion of animals and its causes.
Smithsonian Institution and National Science Foundation,
Washington, D.C.
Pal, R. 1976. Problems of insecticide resistance in vectors of human
disease. Pp. 800-811 in Proc. XV Internat. Congr. Entomology.
Entomological Soci-ety of America, College Park, Md.
Sharpies, F.E. 1983. Spread of organisms with novel genotypes:
146
Thoughts from an ecological perspective. Recombinant DNA
Technical Bull. 6: 43-66.
Shugart, H.H., and D.C. West. 1977. Development of an Appalachian
deciduous forest succession model and its application to
assessment of the impact of the chestnut blight. J. Environ.
Management 5^: 161-179.
Simberloff, D. 1981. Community effects of introduced species. Pp. 79-
107 in B20t2C Cr2ses j_n Eco]_o£j_ca2 and Evolutionary IliHi' ^'^•
M. H. Nitecki. Academic Press, New York.
Sogawd, K. 1982. The rice brown planthopper: Feeding physiology and
host plant interactions. Annu. Rev. Entomol. 2]_: 49-73.
Vanderplank, J.E. 1978. GeneUc and Molecular Basj^s of flant
Pll.!l£2£Il£.lii • Springer-Verlag, Berlin.
147
Environmental Policy Institute
TESTIMONY OF JACK DOYLE
DIRECTOR, AGRICULTURAL RESOURCES PROJECT
ENVIRONMENTAL POLICY INSTITUTE
BEFORE THE SUBCOMMITTEE ON TOXIC SUBSTANCES AND ENVIRONMENTAL
OVERSIGHT OF THE U.S. SENATE COMMITTEE ON ENVIRONMENTAL AND
PUBLIC WORKS
THE INTENTIONAL RELEASE OF GENETICALLY ENGINEERED ORGANISMS
27 September 1984
Mr. Chairman, Members of the the Subcommittee:
For the record, my name is Jack Doyle. I am Director of the
Agricultural Resources Project for the Environmental Policy
Institute (EPI) , a non-profit, public interest organization
engaged in research, public education, litigation and lobbying.
EPI works on energy, environmental and natural resource policy at
the local, state and national levels. We appreciate the
opportunity to appear before this subcommittee today to share our
views on the very important topic of releasing genetically
altered substances into the environment. We commend the chairman
and the members of this subcommittee for initiating these
hearings, and trust that they are only the Senate's first step
into a careful and comprehensive examination of biotechnology and
genetic engineering and how these technologies will affect
society and the environment.
148
During the last three years at EPI I have been working on a
book about some of the changes our society, our nation's food and
farm system, and our environment will likely experience with the
application of biotechnology and genetic engineering to
agricultural production. In the course of writing this book —
which is scheduled for publication early next year — I have
visited with numerous scientists and businessmen in the seed
industry, at new biotechnology companies and at established
corporations.
My discoveries so far leave the distinct impression that
there is much promise for agriculture and the environment with
the use of new genetic technologies. However, there are also
some clear reasons for concern and caution.
Advances and breakthroughs in the science of biotechnology
and genetic engineering have occurred much faster than anyone
anticipated, even as recently as 5 years ago. Huge sums of
capital are being invested in the D.S. and other countries, and a
race has ensued among scientists, new biotechnology companies,
major corporations and even nation states seeking technological
supremacy in world markets. Now in the United States, as
genetically-altered products draw nearer to commercialization,
there is great pressure to secure swift federal approval for
these products. Yet, outside of the House Science and Technology
Subcommittee on Investigations and Oversight, there has been
little public debate or policy forethought on the environmental
or potential social consequences of this new technology. On the
149
environmental question, only a very few reports exist so far,
among them, one prepared by the staff of the House Science and
Technology Subcommittee on Investigations and Oversight in
February 1984, titled, "The Environmental Implications of Genetic
Engineering." Policy-making on the question of environmental
release seems to be evolving more in the courts than it is in the
Congress. But there are potential environmental ramifications
with genetic engineering that need to be debated in the Congress;
potential effects which need to be weighed very carefully before
the federal government commits itself in any one direction.
In the genetic realm alone, there is every reason to be
careful and cautious, and to question iron-clad assurances that
genetic engineering is so exact and precise that everything is
under control and there's nothing to worry about. We've heard
that before. As recently as 1970, plant scientists generally
thought that the genetic traits that determine disease resistance
and/or susceptibility in crops were contained in the nucleus of
the cell. But after the Southern Corn Leaf Blight wiped out 15%
of the nation's corn crop in 1970, they discovered otherwise.
They discovered that cytoplasm — the liquid material contained
in every cell — also had something to do with the genetics of
disease reaction. That was new information.
Today, as in 1970, we continue to learn new things about
genes and how they act. Only in 1983 did we first hear the term
"promiscuous DNA," meaning that DNA sequences could move about
within the confines of the cell, in this case between
150
chloroplasts and mitochondria. Scientists studying this transfer
activity at Duke University and the Carnegie Institution of
Washington conclude that it is not a rare event, but a "general
phenomenon." Before this discovery, scientists had assumed that
intra-cellular organelles like chloroplasts and mitochondria were
independent of each other.* Now they know differently, but how
the DNA gets from one organelle to another is still a mystery.
While the movement of genes between chloroplast and
mitochondria is a new discovery, the knowledge of mobile genetic
elements is not. But sometimes, it has taken the scientific
community a good while to accept such knowledge. In 1951, to the
disbelief of her scientific peers, Nobel prize winner Barbara
McClintock first offered her discovery of "jumping genes."
McClintock discovered that the genes on chromosomes — once
believed to be stationary and therefore predictable in the
genetic characteristics they controlled — could move or "jump"
from one chromosome strand to another, thus affecting changes in
the expression of certain traits. What is most interesting and
instructive about the McClintock episode is that it took nearly
20 years for the scientific community to finally accept her
discovery.
What we may be dealing with in the inner genetic world of
the cell is a system of interactions and adaptations somewhat
*See, for example, Roger Lewin, "No Genome Barriers to
Promiscuous DNA," Science . 1 June 1984.
151
akin to ecological systems of the outside world. That is, there
may be an "ecology of genes" inside of cells and organelles which
operates by principles similar to those of larger-world
ecosystems. What is troublesome about genetic engineering in
such a context is: (1) that these two worlds interact regularly,
and (2) that one small genetic change in an organism might have
large consequences, magnified many times throughout the
environment.
On this last point, the available evidence seems to indicate
— based on the past introduction of exotic species into new
environments, the low rate of survivability of alien organisms in
new environments, and ecological principles of competition and
predation generally — that most genetically-altered organisms
will not survive, but some will, and a few may create problems.*
But we have no way of knowing which ones might cause problems
because we lack what is called a "predictive ecology." We
especially lack a predictive ecology in microbiology, and there
is generally not good interaction between molecular biologists
and ecologists. Further, the science of ecology is young and the
few scientists who ply this field deal primarily with the
ecological give-and-take of organisms in natural ecosystems,
operating under natural rates of mutation and adaptation. Rapid,
*See, for example, "Environmental Implications of Genetic
Engineering," Hearing Before the Subcommittee on Investigations
and Oversight and the Subcommittee on Science, Research and
Technology of the Committee on Science and Technology, U.S. House
of Representatives, 98th Congress, June 22, 1983.
152
man-made genetic changes introduced into these systems by way of
gene splicing introduce a new variable, one that will, without
question, revolutionize the way we think about ecology. Even the
newest textbooks will need to be rewritten.
On the one hand, we have a science of ecology that is young,
not yet "predictive"; on the other, we have a bustling new
industry ready with genetically-altered microbes and other
substances to be released into the environment. Now we are faced
with the question of whether and how government should supervise
such commercial activities. In our opinion, it is not a question
of whether government should regulate, but how. To do otherwise
would be to make the federal government an accomplice in an
ecological crapshoot.
It is clear that a careful debate is necessary about how to
regulate responsibly; one that covers all options and
possibilities; and one that allays public fears and instills
confidence that the new genetically-created substances for
agriculture, mining, enhanced oil recovery, industrial
bioprocessing and other uses will indeed be safe. While
fostering scientific and technological innovation are important
to our country, so are public health and safety and environmental
protection.
But as the regulatory debate moves forward, these are some
steps that can be taken. One is a badly needed infusion of
federal research dollars for EPA, USDA, FDA, and the land grant
universities to insure that we have a predictive ecology in place
153
before new genetically-altered substances are released into the
environment. Moreover, federal funds earmarked for
biotechnological research might build in a predictive or
consequences requirement as a part of all such grants, which
would serve the purpose of inculcating such forethought into the
process at the same the research is being done. The quicker such
measures are taken, the sooner biotechnology products can be
introduced into the environment with some public confidence.
Our concerns for environmental safety and ecological impacts
go beyond establishing a sound predictive science base and a
responsible regulatory framework. Our concerns include the
"potential secondary impacts," the indirect environmental and
agricutural consequences of biotechnology — such as how
biotechnology may exacerbate the unresolved problem of pesticide
safety; how supercrops or supermicrobes may affect the use of
natural resources or the operation of major natural cycles such
as the nitrogen cycle; how biotechnology's expanding use of
microbes (some of which may become pathogenic to plants) in the
processing of industrial products might endanger agricultural
crops; and how the new products of biotechnology will affect the
structure and operation of our nation's family farm system.
When we make genetic changes in crops, livestock and
microbes, we need to ask very broad questions about their
potential environmental and economic impact. If we genetically
alter microbes that move about in the nitrogen cycle, for
example, we must determine what those changes will do to the
154
balance of that system's operation as a whole. If we increase
photosynthetic efficiency in crops by way of genetic engineeringi
will we raise other demands for water and nutrients? If we
engineer and use plant pathogens in certain large scale
industrial processes to make everything from xantham gum to
industrial enzymes, we may increase the risk that such organisms
could escape into agricultural environments where thousand-acre
monocultures invite widespread crop damage?*
*Today, there are at least a dozen known kinds of bacterial
and fungal microorganisms being used to produce a variety of
industrial products and fermented foods — all of which are
capable of producing strains that are pathogenic to crops. With
the aid of biotechnology and genetic engineering techniques, the
number of microbial projects for producing all kinds of
commercial products and intermediaries for industrial processes
is expected to increase significantly.
"Because of the increasing industrial use of plant
pathogens," wrote a team of British scientists investigating
biotechnology for the EEC, "it is important that European
biotechnologists are aware of which organisms might be pathogenic
for European plants. It might be expected that this should
already be the case, but our experience in gathering information
for this report has convinced us that it is not so." Indeed,
these scientists found experienced biotechnologists unaware that
particular organisms they were using or considering were
pathogenic species. And that's not all.
"Just as we discovered biotechnologists unaware that some of
the organisms with which they were concerned belonged to
pathogenic groups," wrote the scientists, "so we found
experienced plant pathologists unaware of current industrial uses
of such organisms." As a remedy to this situation, the British
scientists recommended that two lists be prepared: one
comprising fungi and bacteria that could cause major damage to
crop plants, a second list of current industrial uses of such
organisms. Yet as of this writing, it is unclear whether either
of these lists have ever been prepared for the EEC, or whether
comparable lists exist for the United States. See C.G.T. Evans,
T.F. Preece and K. Sargeant, "Microbial Plant Pathogens: Natural
Spread, and Possible Risks In Their Industrial Dse," A study of
the necessity, content and management principles of a possible
Community Action, Commission of the European Communities,
XII/1059/81-EN. , 74 pp.
155
However, we are most concerned that some developments in
biotechnology and genetic engineering might foster an increase in
the use of certain synthetic pesticides and perhaps exacerbate
some environmental and toxic substances problems with which this
subcommittee is well acquainted. In this regard, the genetic
alteration of agricultural crops to make them withstand the
deleterious effects of herbicides is an instructive example.
Herbicides are chemicals designed to kill plants. However,
some crops have the natural ability to live with some herbicides;
most do not. Wheat has an enzyme which detoxifies the killing
action of Du Font's new herbicide Glean. Corn produces an enzyme
which makes it resistant to the lethal effects of the herbicide
atrazine. Yet, soybeans and alfalfa — two crops that might be
used in rotation with corn — are not tolerant to atrazine.
Similarly, sunflowers, sugarbeets and lentils — crops that might
rotate with wheat — are damaged by the herbicide Glean.
Moreover, these crops can be damaged by these herbicides even
when the chemicals are "carried over" in the soil from previous
applications.
But that's where biotechnology and genetic engineering enter
the picture.* Today scientists use tissue culture techniques in
*See, for example, Jean L. Marx, "Plants' Resistance to
Herbicide Pinpointed," Science . 1 April l^SS; "The Hat market in
herbicides," Chemical Week . 7 July 1982; and "Herbicides follow
the current trend to low-till farming," Chemical Week . 9 May
1984.
156
the lab to screen thousands of cells for potential herbicide-
resistant "survivors." For example, Monsanto 's Plant Sciences
Research Director, Robert J. Kaufman, testifying before a House
subcommittee in June 1982, explained his company's work with
alfalfa plants and the herbicide Roundup. "Alfalfa tissue was
placed into culture first on solid media and later into liquid
culture. In liquid culture, the cells were exposed to a lethal
dose of the herbicide Roundup and the survivors were plated out
for regeneration into whole plants. These new plants (or
variants) were transplanted into the field and treated with
Roundup the way a farmer would use the herbicide. Several
variants were found to have field resistance to the herbicide."'
One recent biotechnology company's prospectus, for example,
it is noted that some U.S. scientists working with tissue culture
techniques have screened and selected out plant cells to
regenerate plants with resistance to the herbicide 2, 4-D,
paraquat, and picloram (Tordon) . In a few cases, scientists have
also cloned genes for herbicide resistance that might be moved
into plants that don't have that resistance now. Such matching
of herbicides and plants genetically-altered to withstand them
will increase the use of chemicals. We believe that this kind of
genetic research and product development will create public
health and environmental problems by increasing the load of
herbicides in the environment. Attached to this testimony is a
157
sample list of companies now using biotechnology techniques and
genetic engineering to incorporate herbicide resistance into new
crop varieties.
Not much is known about the long-term effect of herbicides
in the environment. Although current herbicides are generally
not regarded to be as toxic as the chlorinated hydrocarbon
insecticides used in the 1960s, they do have side effects. Not
much is known about how herbicides completely break down, and
according to some scientists, such information is only known for
about 4 of the 150 herbicide compounds presently in use.*
Herbicides such as atrazine have been found to cause chromosome
breakage and other aberrations in plants. In fact, triazines —
the chemical family to which atrazine belongs — generally are
known to be mutagenic to some insects such as fruit flies.
Moreover, recent revelations about one popular Monsanto
herbicide. Lasso, found in Ohio drinking water, have raised new
*See, for example, D.D. Kaufman and P.C. Kearney, "Microbial
Transformations in the Soil," in L.J. Audus (ed.). Herbicides .
Academic Press, 1976, pp. 29-64.
39-383 0—84 11
158
questions about herbicide safety.* Nevertheless, huge R&D
investments continue to be made in herbicide chemistry, some of
which is now buoyed by the prospect of genetic engineering.
Herbicide-resistant crops are but one area in a whole new
world of agricultural chemistry that biotechnology may create.
Research directors at many of today's leading chemical and
pharmaceutical companies will tell you that they see a much more
sophisticated era of agricultural chemistry ahead — one that
*In June 1984, Pesticide and Toxic Chemical News reported
that EPA might cancel the registration of Lasso because of the
discovery of minute traces of the herbicide in Ohio drinking
water, which suggested that not all of the pesticide dissolves,
as previously claimed. In reaction to that report, Leslie C.
Ravity, a prominent Wall Street analyst for Saloman Brothers,
withdrew his recommendation for the company's stock, causing a
temporary panic in selling. On June 7th, the New York Stock
Exchange halted trading in Monsanto stock for one hour due to the
imbalance in orders. The stock dropped $1.50/share for the day.
Later reports about the possible EPA review of alachlor, the
active ingredient in Lasso, cited links to cancer in laboratory
animals. Lifetime feeding studies with technical grade Alachlor
in mice and rats suggest that the material is capable of causing
tumors in these laboratory animals when it is fed to them in
extremely high levels on a daily basis for the greater part of
their lifetimes, which is not representative of exposure for
humans. The feeding levels in these laboratory animal studies
were many thousand times higher than potential human exposure.
In reaction to the possible EPA review, Monsanto 's Will D.
Carpenter explained: "There is no evidence that Alachlor
produces tumors in humans. The risks will be compared by the EPA
with the benefits from Lasso," he said. "Lasso effectively
controls weeds in major crops including corn and soybeans,
increasing crop yield and quality. It is of major economic
importance to U.S. agriculture.
"These benefits are known to millions of farmers and
documented in economic analyses. The product is being used
safely with no unreasonable risks. Any special review, if held,
would confirm these results and uphold the product's continued
registration. "
159
includes plant growth regulators,* encapsulated and synthetic
seed, new kinds of microbial pesticides, viruses, and
genetically-enhanced bacteria. Who will decide whether these
products are safe, economical and efficient in fostering
agricultural production? Will they be ecologically sound? And
how will the market sort out which ones are truly beneficial and
productive?
Further, assuming EPA has jurisdiction over many of these
new products, what will happen to the agency — already
overloaded with conventional pesticide analysis — when thousands
of genetically-altered products come before it for approval? We
know that existing toxicity data on pesticides already in the
environment are inadequate. The National Research
*While some plant growth regulators may be beneficial and
harmless in the environment, others may not be so benign. In
July 1984, the U.S. Environmental Protection Agency announced a
special review of Uniroyal's growth regulator ALAR, a chemical
spray used on apples to retard ripening. ALAR also makes apples
redder in color and increases their shelf life by 2-to-3 months.
Used in orchards, the spray allows growers to extend the harvest
season, employing fewer pickers over a longer harvest. Used on
peanut crops in the field, the same chemical stimulates upright
growth in the plant, facilitating harvest.
EPA initiated review of this growth regulator because it
feared the substance could pose a dietary cancer risk in humans
consuming raw and processed foods treated with the chemical.
"The order of magnitude of risk from this chemical," said EPA
pesticide official Michael Branagan in July 1984, "is similar to
that of EDB." EPA initiated the review for the chemical when it
discovered in tests on laboratory animals that daminozide, the
chemical's name, caused tumors of the uterus, liver, kidney,
lungs and blood vessels. Uniroyal officials, however, insist
that the chemical is safe- "We don't believe ALAR poses a threat
to either the environment or individuals," said James Sylie,
Uniroyal's manager of crop protection chemicals. The results of
EPA's review will not be known until 19 86. Meanwhile, ALAR
continues to be used.
160
Council recently reported that available data were insufficient
to allow even a partial health assessment for some 66 percent of
pesticide ingredients.* How can we insure that biotechnology
will not spawn still more agricultural chemicals for which little
environmental or toxicity data exist?
Could product research priorities in major corporations and
universities emphasize lines of research that are more
environmentally benign to begin with? Some commercial scientists
have told me, for example, that the reason they are pursuing
herbicide resistance in crops is because it is easy — a
single-gene change in some crops and one of the early gains of
genetic technology. "You have to start with what's there to
demonstrate what can be done," one researcher told me. It is an
understanding, he said, that will lead to other more
sophisticated breakthroughs later. Yet, herbicide-resistant crop
varieties will be commercial products, and it is commercial
products that this new industry wants most to show its
stockholders, its underwriters. Wall Street and the media. While
producing such products may be an innocent and necessary step
along the path of genetic science, it will also be a highly
capitalized step backed by a mass production system that insures
a return on investment.
Our concern here is with momentum — the commercial and
scientific momentum that builds around any new and dynamic
♦Philip M. Boffey, "Few Chemicals Tested for Hazards, Report
Finds," The New York Times. 3 March 1984.
161
technology. Our concern is that a certain kind of product
momentum will be set in motion in the earliest stages of this
technology that may be difficult to turn around should something
go wrong; difficult to reverse because of huge capital
investments, scientific careers on the line, and accrued
political support. This momentum is building now on Wall Street,
here in Washington, and in research laboratories across the
country, and it will shape our agricultural system and the
quality of our environment.
One measure of this momentum now building in U.S.
agriculture, at least partially instigated by the business
expectations for biotechnology, is the shift in the ownership of
seed companies from family-owned businesses to corporate-held
subsidiaries. The name of the game now, in what is rapidly
becoming the agricultural genetics industry, is genes and
expertise, and seed companies with plant germplasm on hand and
plant breeding programs are being snapped up like nobody's
business. We have documented well over 100 such transactions
since 1968, and that is probably a conservative estimate (see
attached chart) . In the last 4 years alone, there have been at
least 50 such transactions, with major corporations such as
AMFAC, Anheuser-Busch, Atlantic Richfield, Cargill, Celanese,
Lubrizol, Monsanto, Rohm & Haas, Royal Dutch Shell, Pfizer,
Stauffer Chemical, and Dpjohn all venturing into the seed
business. Many of these and other corporations have also formed
their own in-house agricultural biotechnology research efforts.
162
or have research contracts with university scientists. Some haver
also bought into biotechnology companies (see attached chart) .
Most biotechnology companies and major corporations working
toward new agricultural genetics products are also moving very
aggressively in the patent area — patenting seeds, genes, and
biotechnological processes. Biotechnology, in other words, is
encouraging a new kind of economic configuration in agriculture
and one that may eventually raise questions of cost for farmers
and price for consumers.
With biotechnology we will be moving to a time when the
alteration of the genomes of agriculture will result in an
alteration of systems of agriculture. Just as we are now paying
attention to the potential ecological consequences of genetic'
engineering, we must also plan for the social and economic
changes that could come to agriculture and rural America with
this revolutionary technology. For example, a genetically
manufactured bovine growth hormone enabling cows to produce 40%
more milk on less feed could have dramatic impacts on the dairy
industry. Some estimates have suggested that if widely used,
bovine growth hormone could result in a reduction of the nation's
dairy herd by one-third. That would mean a dramatic reduction in
farmers and farm numbers. A similar development in the beef or
pork industries would not only affect cattle ranchers and hog
farmers, but also feed grain producers nationwide. These
changes, in turn, might lead to substantial change in federal
farm policy.
163
To summarize, the Environmental Policy Institute finds that
there are benefits and opportunities to come with biotechnolgoy
and genetic engineering in agriculture. There are constructive
applications and inventions that can help to eliminate or reduce
the use of chemicals in the environment, and these should be
pursued sooner rather than later. There should also be
opportunities to diversify our agricultural production base
through the use of new kinds of crops and ways to reduce the
farmer's cost of production with disease-resistant crops and the
development of hardier crops. However, we also believe that
there is need for great caution in the microbial realm, and that
federal regulation and funding for predictive ecology research
are both in order. Indirect and secondary impacts, such as those
possibly resulting from the development of herbicide-resistant
crops, should also be considered. Moreover, there is some need
to examine the consequences of the potential corporate domination
of the genetic substances that will control the growth of crops
and livestock, and thereby the production of food.
Another important issue is the erosion of science in the
public sector, now occurring in agricultural microbiology and
agricultural genetics. We believe that there is a need to keep
public sector science strong and indepedent of commercial goals
so that alternatives are always being freely pursued.
We expect that many of these concerns will be addressed in
the next Congress, and we urge this committee to continue then
what it has started this week.
Thank you for the opportunity to express our views here
today.
Appendices A through E follow.
164
ENVIRONMENTAL POLICY INSTITUTE
Appendices to Accompany the Testimony of Jack Doyle
Director, Agricultural Resources Project
Environmental Policy Institute
Before the Subcommittee on Toxic Substances and Environmental
Oversight of the D.S. Senate Committee on Environment and
Public Works
27 September 1984
Contents
Appendix A
U.S. Biotechnology Companies and Major
Corporations Working on Herbicide-
Resistance in Agricultural Crops
Appendix B
Microbes That Can Be Used in Industrial
Bioprocessing and/or Biotechnology Which
Can Be Pathogenic to Agricultural Crops
Appendix C
Biotechnology Companies and Established
Corporations Involved in Agricultural
Biotechnology
Appendix D
Seed Company Acquisitions, Mergers and
Related Business Ventures, 1968-1984
Appendix E
Corporate Investments, Research Contracts
and Joint Ventures With Biotechnology
Companies for Agricultural and Related
Products
165
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170
Appendix C
BI0TECHN0LCX3Y COMPANIES AND ESTABLISHED CORPORATIONS
INVOLVED IN AGRICOLTORAL BIOTECHNOLOGY
PLANT AGRICDLTORE
ANIMAL AGRICDLTURE
CROP i LIVESTOCK
APPLICATIONS
Advanced Genetic Sciences, Inc. (CAl
Aqcigenetics Corp., (CO)
Allied Corporation
Amf ac
ABCO Plant Cell Research Inst., (CA)
Beatrice Foods
Calgene, Inc. (CA)
Campbell Institute for Research s
■ Technology (NJ)
Cargill
Cetus Corp. (CA)
Ciba-Geigy
Crop Genetics International (HD)
DNA Plant Technology (NJ)
Ecoqen (NJ)
E.I. du Pont (DL)
Elli Lilly i Co. (IN)
PMC Corp.
Frito-Lay, Inc. (TX)
General Foods Corp (NY)
Genetics Institute (MA)
Hawaii Biotechnology
Group, Inc. (HI)
Hilleshog
International Plant Research
Institute (CA)
Kellogg Co.
Koppers Co.
Martin Marietta (MD)
Miller Brewing Co. (Wl)
Nabisco Brands, Inc. (NY)
Native Plants, Inc. (VT)
Phytoqen (CA)
Phyto-Tech Lab (CA)
Phyto Dynamics, Inc. (IN)
Pioneer Hybrid International
Corp. (lA)
Plant Genetics, Inc. (CA)
Rohm k Baas (PA)
Royal Dutch Shell
Standard Oil of Indiana (CA)
Standard Oil of Ohio (OH)
Stauffer Chemical Co. (CN)
Sungene Technologies Cor. (CA)
Dniversal Foods Corp (WS)
Union Carbide
Xenogen, Inc. (CN)
Advanced Genetic Res. (CA)
Ambico Inc. (10)
AmericanQualex (CA)
Animal Vaccine Res. (CA)
Antibodies, Inc. (CA)
Applied Genetics, (NJ)
Atlantic Antibodies (ME)
Bethesda Res. Lab (MD)
Bio-Con Inc. (CA)
Biogen, Inc. (HA)
Biotechnlca Int. (MA)
Bio-Technology General (NY)
California Biotech (CA)
Cambridge Biosci. Corp. (CA)
Centaur Genetics Corp. (ID
Cetus Corp. (CA)
Chiron Cor. ICA)
Diamond Laboratories (10)
Diamond Shamtoclt Corp. (OH)
Indiana Siolab (IN)
Int. Plant Res. Inst.
Lederle Laboratories (NJ)
Llpsome Co. Inc. (NJ)
Liposome Technology (CA)
Mercl( & Company (NJ)
Miles Laboratories (IN)
Molecular Genetics (MN)
Monoclonal Antibodies (CA)
Phillips Petroleum
Multivac, Inc. (CA)
Neogen Corp. (MI)
Norden Laboratories ^NB)
Repllgen Corp. (MA)
Ribl Immunochem Res. Inc. (MT)
Salk Institute Blotech/Ind. (CA)
Schering-Plough Corp. (CA)
SDS Biotech Corp. (OH)
SmlthKllne Bechman (PA)
:;ynbiotex Corp. (CA)
Synergene (CO)
Synqene Products i Res. (CO)
Syntax Corp. (CA)
Syntro Corp. (CA)
Onlgene Laboratories (NJ)
American Cyanamid (NJ)
Abbott Laboratories
Amgen(CA)
Biotechnica Int. (MA)
Bio-Tech. Gen. (NY)
Centaur Genetics (ID
Dow Chemical (ID
Enzo Biochem (NY)
M.R. Grace (MD)
a. J. Heinz Co.
Indiana BioLab (IN)
Int. Genetic Sciences Part. (NY)
Int. Minerals 4 Chem (IN)
DeKalb AgResearcb Inc. (ID
Molecular Genetics (MN)
Monsanto (MO)
Multivac (CA)
Neogen Corp. (MI)
Pfizer (NY)
A.E. Staley MPG. (ID
Opjohn Co. (MI)
Worne Biotech, Inc. (NJ)
Zoecon Corp. (CA)
SQurcfti Data complied by the Environmental Policy Institute, Vfash., DC from various industry
reports, newspaper accounts and Congressional Office of Technology Assessment
Report, Commercial R1 nfi^rhnfil nay; An rm-ernat < nna 1 Analy-ii-i (19S4).
171
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199
TESTIMONY OF JEREMY RIFKIN
BEFORE THE U.S. SENATE COMMITTEE
ON ENVIRONMENT AND PUBLIC WORKS
HEARINGS ON THE POTENTIAL CONSEQUENCES
OF GENETIC ENGINEERING
Jeremy Rifkin
Foundation on Economic Trends
13^6 Connecticut Avenue, NW, #1010
Washington, D.C. 20036
(202) ^66-2823
200
STATEMENT BY JEREMY RIFKIN
My name is Jeremy Rifkin and I am president of the Foundation on Economic
Trends. In order to undertake a thoughtful examination of the potential
environmental impacts of the biotechnical revolution, it is first essential to
place this technology within a historical context. With genetic engineering,
we begin the process of reorganizing our entire relationship to natural
systems. In sheer scope and magnitude, the genetic engineering revolution
closely parallels the revolution in fire technology which has established the
framework for our traditional approach to nature. For thousands of years
we have been burning, soldering, forging, heating and melting the earth's
crust, transforming inert materials into new shapes, combinations and forms.
We have produced steel, glass, cement, cinnabar and synthetics using fire or
pyrotechnology. Now, with the use of genetic engineering technology,
biologists are able to recombine genetic material from unrelated species and
in so doing, create modified and novel forms of life that have never
previously existed in nature. The transition from the age of pyrotechnology
to the age of biotechnology raises fundamental environmental questions,
some of which I would like to briefly outline.
First, genetically engineered products differ from petrochemical products in
several important ways. Because they are alive, genetically engineered
products are inherently more unpredictable than petrochemical products in
the way they interact with other living things in the environment.
Consequently, it is much more difficult to assess all of the potential impacts
that a biotechnical product might have on the earth's ecosystems.
In addition, genetically engineered products reproduce, grow and migrate.
Unlike petrochemical products, it will often be difficult or impossible to
constrain them within a given locale. Finally, once released, it is virtually
impossible to recall living products back to the laboratory, especially those
products that are microscopic in nature. For all these reasons, genetically
engineered products pose even greater long-term potential risks to the
environment than petrochemical products.
201
In the coming decades, it is more than likely that industry will introduce
thousands of new genetically engineered products into the open biosphere
each year just as industry has introduced thousands of petrochemical
products into the environment each year. While many of these genetically
engineered organisms will prove to be benign, sheer statistical probability
suggests that a small percentage will prove to be dangerous and highly
destructive to the environment. In fact, the long-term cumulative impact of
thousands upon thousands of introductions of genetically modified organisms
could well eclipse the damage that has resulted from the wholesale release
of petrochemical substances into the earth's ecosystems.
Secondly, genetic technology, as it is applied in the fields of agriculture and
animal husbandry, is designed to increase the speed of maturation and gross
productivity of plants and animals beyond the limits imposed by solar
production and natural recycling. The objective is to transform biological
materials into useful products in an ever accelerating production tempo.
The great myth of the emerging genetic engineering revolution in agricul-
ture is that the ever accelerating production of living products can be suc-
cessfully managed without ever exhausting the reservoir of life support
systems that are essential for maintaining the reproductive viability of
living organisms in the future. The point is, living resources are as finite
and depletable as fossil fuels.
For example, let us take the case of attempts to genetically engineer new
plants that could absorb greater sunlight and increase the rate of
photosynthesis. While the benefit of such a procedure seems apparent at
first glance, a closer examination reveals the price that would have to be
paid to achieve the desired results. Increased photosynthesis would require a
greater use of soil nutrients, thus threatening the further depletion and
erosion of an already endangered agricultural soil base. Soil depletion and
erosion is one of the major problems in modern agriculture today. Attempts
to genetically engineer increases in speed of maturation and gross
202
productivity will place additional burdens on an already overtaxed soil
structure, thus posing the very real danger of inadequate nutrient reserves
for sustaining future agricultural crops.
Thirdly, transferring genetic traits from one species into the permanent
hereditary code of another species poses grave long-term environmental
dangers and raises fundamental moral questions. Recombinant DNA tech-
niques allow researchers to cross species boundaries, violating a basic
ecological principle. Mating walls in nature maintain the biological Integrity
of each discrete species and establish a context for stable interaction
between species. Without well defined mating walls, nature would cease to
exist. Recombinant DNA provides a tool for bypassing species boundaries.
It is now theoretically possible, and in some cases, practically possible, to
transfer genetic traits between totally unrelated species. The long-term
cumulative impact of imposing foreign genetic material into the hereditary
blueprint of a species could well lead to serious health problems for each
succeeding generation of that species and could ultimately result in the
extinction of the species.
Then there is the ethical issue raised by the transfer of genetic traits
between species. Imposing foreign genes into the hereditary blueprint of a
species violates the telos or integrity of each creature. This represents the
most cruel form of treatment as it robs each species of their unique genetic
make-up. Transferring traits between species demonstrates a total lack of
regard for the principle of species borders, a principle woven into the very
fabric of biological and ecological systems.
203
For all the above stated reasons, it is my opinion that attempts to geneti-
cally engineer microbes, plants and animals is tantamount to playing ecolog-
ical roulette. The earth's ecosystems are complex, highly synchronized and
finely balanced. Are we wise enough and smart enough to begin the process
of redesigning the blueprints of living systems without destroying the very
foundations of the earth's environment?
I find it ironic that government agencies and Congress have limited the
debate of genetic engineering to the question of how to proceed and how to
regulate. Why is it that virtually no attention has been given to the question
of whether, in fact, we should proceed at all with this radical departure in
the way we organize and relate to the rest of the living kingdom? Genetic
engineering raises the most important social policy question that the human
family has ever had to face. Do we begin a long journey over the next
several hundred years in which we increasingly become the designers and
architects of life itself? Would it not be more prudent at this stage to begin
with a spirited public debate on all the benefits and costs of embarking on
such a revolutionary change in the way we conceptualize our existence? It
is a sad commentary on the nature of our political process that the
governmental powers are more than willing to legitimize the full scale
application of this technology into the economic and social life of our
society even before the citizenry has had the opportunity to be fully
informed of the many issues raised by this emerging technological
revolution. How can the public advise their elected leaders of their will in
regard to the many issues raised by genetic engineering technology when
they have not yet been informed of the short and long-term implications of
engineering and introducing genetically modified living products into the
environment?
When it comes to the question of regulation, the first order of business is to
ask whether a "science" exists by which to judge the risk of introducing
genetically engineered products into the environment. While we have a
science of toxicology for judging the risk of introducing petrochemical
204
BOSTON PUBLIC LIBRARY
3 9999 05706 0897
products, we have not yet even attempted to develop a set of scientific
protocols and a methodology to ascertain the risks involved in introducing
genetically modified organisms into the biosphere. In the absence of a
predictive ecology methodology, it is foolhardy to even entertain the idea of
regulation. Afterall, how can an agency regulate when no scientific
procedure exists to judge the potential risk of genetically engineered
products? It is possible that, in the final analysis, a risk assessment
methodology might be impossible to establish. If that turns out to be the
case, I, for one, believe that we have a responsibility to take the more
conservative and responsible course of action — to reject the introduction of
any genetically engineered products into the environment.
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